10 Boston Scientific jobs in Ireland
Senior Research & Development Engineer (Vascular)
Limerick, Munster
Cook Medical
Posted 4 days ago
Job Viewed
Job Description
Overview The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices for the Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Senior Research and Development Engineer: Design development Prototyping and test method design. Design and/or process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner. Product and project risk analysis and risk management. Develop prototypes which are consistent with the clinical and design requirements of the project. Research new therapies and design solutions to develop and complement the existing product portfolio. Introduce new equipment, materials and technologies. Generation of Design History File documentation. Support of regulatory submissions. Work closely with Key Opinion Leaders (KOL's), physicians and product managers to develop innovative medical devices to improve patient care. Project lead for assigned Research and Development team/s including technical and project management leadership responsibly. Lead technical development of projects. Lead all key design decisions to ensure quality design selection. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. Work closely to build effective relationships with cross functional groups to achieve project and company goals. Retrospective project reviews to understand lessons learned. Manage device evaluations. Compliance with Quality, Regulatory and company policies and systems. Mentoring, coaching and development of team members if required. Foster innovation and creativity within team and perform disclosure reviews. Ensure compliance with Quality, Regulatory and company policies and systems. Communications: Regular communication to cross-functional teams, senior management and business unit leaders. Project status communications and reporting. Remain on the forefront of emerging industry practices. Instrumental in driving and implementing change to improve departmental and company performance. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Act as a designee for the Manager, Research and Development or Team Lead, Research and Development. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree required, preferably in engineering or a related field. Minimum of 5 years' relevant experience is required. Experience in Product Development projects within Medical Device or regulated industry/adjacent experience. Proven project/technical experience. Project management methodology and skills. Proven experience working closely with project managers. Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards. Strong statistical understanding and experience e.g. DOE and/or Gage R&R. Strong technical writer. Good working knowledge of Solidworks and/or Pro Engineer CAD. Experience of medical device development from concept through to commercialisation. Ability to effectively translate needs of clinicians and Strategic Business Unit into project inputs. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #IrishJobs To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
This advertiser has chosen not to accept applicants from your region.
0
Senior Research & Development Engineer I Sustaining & Lifecycle
Galway, Connacht
J&J Family of Companies
Posted 12 days ago
Job Viewed
Job Description
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity?Learn more at Function:**
R&D Product Development
**Job Sub** **Function:**
Biomedical Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**Role: Senior Research & Development Engineer I Sustaining & Lifecycle Management**
**Location:** Ballybrit, Galway
**Reports to:** R&D Project Manager
**Live Our Credo & Pursue Our Purpose:**
As part of the Johnson & Johnson family of companies, Our Purpose is 'We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.' We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
**Diversity, Equity & Inclusion:**
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".
**JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR offers a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
**What is it like to work at JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR Galway?**
+ Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
+ We are continuing to better our understanding of clot science through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and advance the treatment of acute ischemic stroke.
+ Strong new product pipeline and a fast-growing medical device company within J&J.
+ From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.
**Job Summary:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR a Johnson & Johnson company is recruiting for a Senior Research and Development Engineer, Sustaining and Lifecycle Management, in Galway Ireland.
The role of Senior R&D Engineer I supports managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges. Overall responsibility for various aspects of the product's lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.
**The responsibilities and the impact YOU will have:**
+ Acquire an in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process.
+ Product/Process optimization projects - in liaison with Supply Chain and Quality.
+ Support second supplier and/or technical transfer projects.
+ Manage project sub-parts, as part of a larger project team.
+ Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
+ Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
+ Lead product Shelf-Life studies through Design Verification testing.
+ Investigations on product complaints and analysis of returned devices
+ Support to CAPA and Non-Conformance process.
+ Evaluation and scoping of process changes, material changes, vendor changes.
+ Support to Labelling changes and implementation.
+ Support to Sales and Marketing for product characterization, competitive testing, field training.
+ Develop and deliver project plans to performance, time and cost targets.
+ Leverage and liaise with external resources, including suppliers, to achieve project goals.
+ Identify and manage of key risks throughout the product lifecycle.
+ Write procedures, protocols, specifications, and reports.
+ Evaluate and assess physician (user) techniques and develop product training materials.
+ Support developing marketing materials (presentations/videos/demos).
+ Other duties as assigned or required.
**We would love to hear from YOU, if you have the following essential requirements:**
+ A minimum of 4 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
+ Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
+ Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
+ Data review and statistical methods skills (Minitab).
+ Strong work ethic, creative problem solving, capable of working on own initiative.
+ Excellent writing, presentation, and verbal communication skills essential.
+ Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
**Location & Travel**
+ This role will be an onsite role based in Galway, Ireland with flexible work arrangements from time to time in agreement with management and per the J&J Flexible Work policy.
+ As part of a global company, travel may be required from time to time, up to 20%.
**This is what awaits YOU:**
This is an opportunity to work with a ground-breaking biomedical. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you're one of the people who already work here, or you're considering joining the team, we offer:
+ An opportunity to be part of a global market leader.
+ A dynamic and inspiring working environment.
+ Opportunities to work on challenging projects and assignments.
+ Possibilities for further personal and professional development/education.
**Equal Opportunity:**
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
R&D Product Development
**Job Sub** **Function:**
Biomedical Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**Role: Senior Research & Development Engineer I Sustaining & Lifecycle Management**
**Location:** Ballybrit, Galway
**Reports to:** R&D Project Manager
**Live Our Credo & Pursue Our Purpose:**
As part of the Johnson & Johnson family of companies, Our Purpose is 'We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.' We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
**Diversity, Equity & Inclusion:**
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".
**JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR offers a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
**What is it like to work at JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR Galway?**
+ Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
+ We are continuing to better our understanding of clot science through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and advance the treatment of acute ischemic stroke.
+ Strong new product pipeline and a fast-growing medical device company within J&J.
+ From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.
**Job Summary:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR a Johnson & Johnson company is recruiting for a Senior Research and Development Engineer, Sustaining and Lifecycle Management, in Galway Ireland.
The role of Senior R&D Engineer I supports managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges. Overall responsibility for various aspects of the product's lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.
**The responsibilities and the impact YOU will have:**
+ Acquire an in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process.
+ Product/Process optimization projects - in liaison with Supply Chain and Quality.
+ Support second supplier and/or technical transfer projects.
+ Manage project sub-parts, as part of a larger project team.
+ Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
+ Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
+ Lead product Shelf-Life studies through Design Verification testing.
+ Investigations on product complaints and analysis of returned devices
+ Support to CAPA and Non-Conformance process.
+ Evaluation and scoping of process changes, material changes, vendor changes.
+ Support to Labelling changes and implementation.
+ Support to Sales and Marketing for product characterization, competitive testing, field training.
+ Develop and deliver project plans to performance, time and cost targets.
+ Leverage and liaise with external resources, including suppliers, to achieve project goals.
+ Identify and manage of key risks throughout the product lifecycle.
+ Write procedures, protocols, specifications, and reports.
+ Evaluate and assess physician (user) techniques and develop product training materials.
+ Support developing marketing materials (presentations/videos/demos).
+ Other duties as assigned or required.
**We would love to hear from YOU, if you have the following essential requirements:**
+ A minimum of 4 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
+ Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
+ Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
+ Data review and statistical methods skills (Minitab).
+ Strong work ethic, creative problem solving, capable of working on own initiative.
+ Excellent writing, presentation, and verbal communication skills essential.
+ Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
**Location & Travel**
+ This role will be an onsite role based in Galway, Ireland with flexible work arrangements from time to time in agreement with management and per the J&J Flexible Work policy.
+ As part of a global company, travel may be required from time to time, up to 20%.
**This is what awaits YOU:**
This is an opportunity to work with a ground-breaking biomedical. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you're one of the people who already work here, or you're considering joining the team, we offer:
+ An opportunity to be part of a global market leader.
+ A dynamic and inspiring working environment.
+ Opportunities to work on challenging projects and assignments.
+ Possibilities for further personal and professional development/education.
**Equal Opportunity:**
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This advertiser has chosen not to accept applicants from your region.
1
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
Dublin, Leinster
€125000 - €150000 Annually
Novartis Farmacéutica
Posted 3 days ago
Job Viewed
Job Description
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
Job ID REQ-
Irlanda
SummaryLocation: Barcelona or Dublin
In this role you will effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting the customer expectations while assuring solutions are safe, reliable, scalable and flexible.
You will act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. You will also engage with global business leaders and leverage the appropriate Data Digital and IT (DDIT) teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value
Role Responsibilities:
- Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
- Develop project rationale and perform scoping assessments to determine feasibility of projects. Highlight/identify gaps in existing functionality and review requirements with stakeholders.
- Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions. Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.). Liaise with the service development team to suggest a high level functional solution.
- Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services.
- Ensure the overall user experience is taken into account when designing and deploying new solutions and services.
- Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT )
- Ensure implemented solutions are according to specifications and fit for purpose.
Support super user training.
Role Requirements:
- University degree in Informatics, Computer Sciences, Life Sciences or similar
- A minimum of 10+ years of experience in working in the Pharma or IT Industry with 8+ years of experience in the Lab IT domain
- A minimum of 6+ years of experience as a business analyst/process expert/ business IT lead superuser/Lab data or Digital position
- Expert understanding of business process analysis & design and system architecture concepts.
- Expert understanding of the Lab business processes, drug development experience an advantage
- Expert knowledge of GXP, 21CFR Part 11 and the CSV lifecycle
- Expert knowledge of Lab systems including LIMS systems, and Chromatography systems.
- Ability to solve complex business process / information challenges.
- Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
- Working knowledge of Project Management, agile an advantage
- Prior working experience in TRD and knowledge on TRD business processes is preferred.
- Innovation experiences an advantage, including digital innovation projects
- Data Strategy, Data science or data standardization experience an advantage.
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours
Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
This role is based in Barcelona, Spain OR Dublin, Ireland. Novartis is unable to offer relocation support for this role:please only apply if this location is accessible for you
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
This advertiser has chosen not to accept applicants from your region.
2
2025 - Deloitte Aspire Programme - Research & Development - Global Investment & Innovation Incentiv
Dublin, Leinster
Deloitte Ireland LLP
Posted 4 days ago
Job Viewed
Job Description
Why Choose to Apply to the Deloitte Aspire Programme? The Deloitte Ireland Aspire Programme, launched in 2020, supports professionals in the international protection process and under temporary protection to secure employment opportunities and develop their career in Ireland. Deloitte partners with the Irish Refugee Council , Business in the Community Ireland , Open Doors , Nasc and DLA Piper to offer a 6 month work placement across our business. During the 6-month period, participants are supported to deliver impactful work on client and internal projects and gain experience within the Irish market. You will also partake in coaching to explore career growth areas and join our community to build a network. This 6-month work placement programme will begin with Deloitte Ireland in Dublin from September 2025. Successful candidates will be paid for duration of the internship. Benefits of the Aspire Programme: Real client projects and the opportunity to learn from industry leaders. Insights into the business world in an Irish market. Continual learning & professional skill development opportunities. A supportive buddy and People Leader system. Career growth potential. At Deloitte, we celebrate the individuality that each team member brings-whether it's their ideas, interests, or personality. This diversity is key to our culture and success. At Deloitte Ireland, we're a team of over 3,000 talented individuals. As our firm grows, we remain committed to leadership across four key business areas: Technology & Transformation, Audit & Assurance, Tax & Legal and Strategy Risk & Transaction Advisory. We partner with some of the largest companies in Ireland and globally, providing opportunities for you to make a real impact across multiple industries. Join us and be part of a global network of nearly 400,000 people across 150 countries. Why Choose a Career in our R&D tax credits and incentives - Gi3 team? As a Research & Development Intern, you will be part of a team of talented Tax individuals with background in the most varied areas such as Computer Science, Accounting, Food Science, Life Science, Finance & Economics. Global Investment and Innovation Incentives (Gi3) are Deloitte's leading experts in research and development (R&D) incentives. The team (which resides within the Tax department) in Deloitte helps companies, that are on the cutting edge of science and technology, claim tax relief on costs that are incurred in carrying out R&D activities on a yearly basis. We advise companies as how to identify strong R&D projects that our clients are undertaking, help them to explain those projects in the context of the current state of the art and work with them to draft technical reports and financial calculations to align those projects to the legislative requirement of the R&D tax credit regime. Our specialist team is an eclectic mix of STEM and financial professionals who work closely together in the provision of R&D tax credit claims for some of the most interesting and dynamic companies in Ireland, from startups to some of the largest multinationals in the world. What you will be doing: You will gain experience in a client facing role working on different projects with wide range of clients from different sectors, including software, electronics, food science, biotechnology, pharmaceutical, manufacturing, petrochemical, aerospace, and chemical science. As a member of the team, you will have the opportunity to encounter cutting edge technology across every field of STEM Review and analyse scientific/technological aspects of R&D activities undertaken by companies, from privately-owned businesses to major multinational corporations See, understand, and help fund cutting edge research and development projects in the field of science or technology that you are passionate about Support the next generation of Green and Sustainable technologies and products Work on client projects, helping conduct technical interviews with innovation leaders to understand the R&D undertaken and preparing documentation for Irish Revenue and grant awarding bodies such as the IDA or Enterprise Ireland Assist, using your knowledge and experience, clients align their activities to the qualification criteria of the R&D Tax Credit and various grants Assist in the drafting & reviewing of technical project reports, that describe the technical objectives and activities of clients' projects and support their R&D claims Assist in the preparation of R&D Tax Credit financial calculations Assist in the supporting of R&D Tax Credit claims in the event of Revenue Audit/ enquiries Assist in the identifying and exploring other R&D funding opportunities with clients Roles and responsibilities Draft and review technical project reports to support R&D claims. Prepare R&D Tax Credit financial calculations. Assist in supporting R&D Tax Credit claims during Revenue audits or inquiries. Identify and explore additional R&D funding opportunities for clients. What we're looking for: We are looking for someone who is curious and resilient, a proactive collaborator and adaptable . Excellent written and spoken English language skills are required . Accountability, p rioritisation and ability to take initiative and manage multiple tasks . Ready to Launch Your Career? Apply Today! ? Location: Hybrid roles based in Dublin ? Important: You can apply to only one Aspire program role-choose wisely! Applications close on Tuesday the 12th of August at 4pm. ? Follow us on Instagram for an inside look at Life at Deloitte! Requirements: You must have the right to work in Ireland and currently be residing in Ireland to apply for this programme. International professionals that hold the right to work in Ireland under the following visas / permissions are eligible to apply: Stamp 4, Stamp 1, Labour Market Access permission, Temporary Protection permission Experience working in professional services, a corporate environment or a related field is desired. You are looking to develop new skills, learn and grow your career in professional services. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
This advertiser has chosen not to accept applicants from your region.
3
AI Research and Development Engineer
Dublin, Leinster
Moofwd Limited
Posted today
Job Viewed
Job Description
Job Description: We are seeking highly skilled and innovative individuals to join our new AI division. As AI Research and Development Engineers, you will play a crucial role in conducting research and developing cutting-edge AI technologies to enhance our products and services across the company. Working under the guidance of a Technical Lead, you will collaborate with cross-functional teams to identify AI opportunities, design solutions, and implement AI systems to address business challenges. This role requires strong technical expertise in AI algorithms and machine learning techniques, as well as the ability to work effectively in a collaborative, fast-paced environment. Key Responsibilities: Conduct research and development of AI technologies to drive innovation and create competitive advantage for the company. Collaborate with product managers, engineers, and other stakeholders to identify AI opportunities and define project requirements. Design and implement machine learning models, algorithms, and AI systems to solve specific business problems and improve product performance. Analyze large-scale data sets to extract insights, identify patterns, and develop predictive models. Stay updated on the latest advancements in AI research and technology trends, and evaluate their potential applicability to company projects. Assist in the development of AI prototypes and proof-of-concepts to demonstrate feasibility and potential impact. Work closely with senior team members to refine AI solutions, optimize performance, and ensure alignment with technical standards and best practices. Collaborate with external partners, academia, and research institutions as needed to leverage expertise and resources for AI projects. Communicate progress, findings, and recommendations to project stakeholders and contribute to technical documentation and reports. Qualifications: Masters or Bachelor degree in computer science, artificial intelligence, machine learning, or a related field. Strong understanding of machine learning techniques, including supervised and unsupervised learning, deep learning, reinforcement learning, and natural language processing. Proficiency in programming languages such as Python, R, or Java, and experience with AI frameworks and libraries (e.g., TensorFlow, PyTorch, scikit-learn). Experience working with large-scale data sets and applying statistical analysis and data mining techniques to extract insights and build predictive models. Excellent problem-solving skills and ability to independently research, analyze, and implement AI solutions to address complex business problems. Effective communication and collaboration skills, with the ability to work well in a team environment and contribute to cross-functional projects. Eagerness to learn and stay updated on emerging technologies and industry trends in AI and machine learning. Previous experience with AI research or development projects, internships, or coursework is a plus. Passion for AI and a strong desire to contribute to impactful projects that leverage cutting-edge technology. This position offers an exciting opportunity to be part of a dynamic team driving AI-driven innovation within our company. If you are passionate about AI and eager to apply your skills to real-world challenges, we encourage you to apply. Skills: AI ML Data Analysis Benefits: Laptop
This advertiser has chosen not to accept applicants from your region.
4
Medical Device Product Specialist
Limerick, Munster
Pale Blue Dot® Recruitment
Posted 2 days ago
Job Viewed
Job Description
Medical Device Product Specialist | Nationwide (Ireland)
Are you a confident communicator with a passion for healthcare and innovation? A dynamic opportunity awaits for an ambitious individual to join a forward-thinking medical device organization as a Medical Device Product Specialist . If you're driven by results, eager to grow your career, and excited to work at the intersection of science, technology, and patient outcomes — this could be your next big move.
The Ideal Candidate :
All candidates must hold a third-level qualification (minimum: NFQ Level 8 – Honors Bachelor Degree) and ideally bring 3+ years of experience from one or more of the following areas:
Healthcare (clinical, surgical, or healthcare-related background – an advantage, but not essential as training is provided)
Business (B2B Sales, Marketing, Finance, Accounting, Commerce)
Engineering (Biomedical, Biochemical)
Science (Microbiology, Biochemistry, Neuroscience, Mathematical Sciences, Biology, R&D)
Our Client is looking for someone who:
Is a self-starter with an entrepreneurial drive and a hunger to succeed.
Has a natural flair for presenting, with the ability to communicate complex technical information in an engaging, relatable way.
Approaches challenges with a solution-focused mindset and thrives under pressure.
Enjoys building genuine relationships and sees value in long-term client trust.
Is eager to continuously learn, grow, and evolve within a commercial healthcare setting.
Responsibilities include but are not limited to:
Setting and achieving territory business development goals and sales targets
Promoting a portfolio of surgical devices and healthcare solutions to medical professionals
Building and maintaining strong customer relationships based on credibility and trust
Gathering and sharing market intelligence, including customer feedback, competitor activity, and emerging opportunities
Representing the brand at meetings, product demonstrations, workshops, and industry events
Collaborating with internal teams to ensure high levels of customer service and operational excellence
NFQ Level 8 Honours Bachelor Degree in a relevant discipline (Healthcare, Business, Engineering, or Science)
Minimum 3 years of experience in a relevant industry
Strong interpersonal, communication, and public speaking skills
Proven ability to manage a territory and work autonomously
Full, clean driving licence (essential)
Must be currently residing in Ireland
Willingness to travel nationwide
A long-term vision to develop within the healthcare sales and marketing field
What’s on Offer: Competitive base salary with bonus structure; Company car, expenses, and pension contribution ; Comprehensive training and onboarding; Supportive team culture focused on innovation and continuous improvement; Opportunity to join a growing company and make a real impact in the medical device sector
Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.
Pale Blue Dot® Recruitment
The Experts in STEM Workforce Solutions
This advertiser has chosen not to accept applicants from your region.
5
Occupational Health Nurse Medical Device
Galway, Connacht
Head-Hunt International
Posted 4 days ago
Job Viewed
Job Description
Occupational Health Nurse Qualified Occ Health Nurse Location: Galway Permanent Full Time Position Monday Friday On site only role Excellent Benefits Connaught Salary euro An established multinational medical device manufacturing company in Galway is currently recruiting a qualified Occupational Health Nurse to work on site in Galway. We offer a favourable package and working environment with a strong focus on development. Requirements: A recognised qualification in Occupational Health is essential for this role. Registered General Nurse with a valid NMBI registration Excellent communication skills with strong interpersonal, empathy and listening skills. Strong organisational and planning skills including time management with proven track record of prioritizing key tasks and delivery to a high professional standard. Strong team member with proven ability to establish and maintain effective working people relationships. Minimum of 2 years plus of experience in occupational health nursing. Occupational Health Nurse duties: * Case management triage for all HR referrals, with OHN initial assessment and booking into OP diary. OP visits half day per week. * Health surveillance 2 yearly recalls * Vision assessment annually * Work related injury follow up * Flu clinics annually If you are a highly motivated and experienced OH Nurse looking for a new challenge, we encourage you to apply for this exciting opportunity. We would be delighted to hear from you. This is an exciting opportunity to get your foot in the door of an excellent reputable organisation. Salary is excellent & negotiable for the right candidate, excellent benefits, flexible hours & much more! 5 days per week on-site Monday to Friday generally 8am - 4:30pm or 8.30am 5pm. IND1 For more information call Maria O' Dwyer today on or for more information on this client & a confidential chat please call Maria on or email Maria on Skills: Occ Health Nurse Occupational Health Nurse NMBI Nurse #occhealthnurse#occupationalhealthnurse#nmbi#Galway Skills: Occupational Health Nurse Occ Health Nurse Occ Health Nurse Medical Device Galway Benefits: excellent
This advertiser has chosen not to accept applicants from your region.
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6
Manager, Medical Device and Combination Product Quality Systems
Sligo, Connacht
AbbVie
Posted 14 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
7
Manager, Medical Device and Combination Product Quality Systems
Westport, Connacht
AbbVie
Posted 14 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
8
Manager, Medical Device and Combination Product Quality Systems
Dublin, Leinster
AbbVie
Posted 14 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport, otherwise in one of our other Ireland sites.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
9