17 Medical Device jobs in Ireland

Territory Manager (Medical Device)

Dublin, Leinster Adecco

Posted 1 day ago

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Join the Frontlines of Surgical Innovation - Territory Manager (Surgical) Territory: Dublin & South/South East Ireland About the Company Our client is a leading player in the medical distribution sector, known for delivering innovative healthcare solutions across Ireland and beyond. With a strong reputation for excellence, they partner with world-class suppliers to bring cutting-edge surgical and medical technologies to hospitals and healthcare providers. Their team is driven by a shared commitment to improving patient outcomes, supporting clinical excellence, and fostering long-term customer relationships. This is a company where your expertise will be valued, your ideas welcomed, and your career supported through continuous development and meaningful work. If you're looking to join a forward-thinking organisation that's shaping the future of healthcare, this is the opportunity for you. What You'll Be Doing Drive Revenue Growth: Own your territory and exceed monthly revenue and margin targets. Strategic Sales Planning: Forecast demand, manage pipeline reports, and execute account plans. Customer Engagement: Build strong relationships with hospitals, clinicians, and procurement teams. Supplier Collaboration: Work closely with global suppliers to resolve customer issues and stay ahead of market trends. Industry Presence: Represent the brand at trade shows, conferences, and training workshops. Some in In theatre support (elective) Your Territory Covering key regions including South Dublin, Cork, Waterford, Wexford, Kilkenny, Clonmel, and Laois. You'll be on the move, engaging directly with customers and occasionally traveling to the UK and EMEA for supplier meetings and industry events. Candidate would be ideally placed in Dublin or surrounding areas. What We're Looking For Experience: 2+ years in medical device sales, ideally in surgical or theatre environments, though not a necessity. Track Record: Proven success in the Irish medical market, especially with procurement teams. Knowledge: Strong grasp of clinical and technical detail, with the ability to communicate fluently with healthcare professionals. Tech Savvy: Comfortable with Outlook, Word, Excel, and CRM tools (Salesforce experience a plus). Education: Degree in a scientific, medical, or business discipline preferred. Personal Attributes Exceptional communication and influencing skills Customer-first mindset with a passion for delivering value Commercially astute with a hunger for business growth Self-motivated, dynamic, and solution-oriented Organised and able to prioritise effectively Full driving license required Why This Role? This is more than just a sales job. It's a chance to be part of a high-performing team that's transforming surgical care across Ireland. If you're enthusiastic, strategic, and ready to make a difference, we want to hear from you. Competitive base salary, bonus, pension, lunch allowance and company car Ready to take the next step in your career? Apply now and become a key player in shaping the future of surgical innovation. Adecco Ireland is acting as an Employment Agency in relation to this vacancy. Skills: surgical sales medical Benefits: Work From Home pension bonus company car
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Medical Device Product Specialist

Limerick, Munster Pale Blue Dot® Recruitment

Posted 7 days ago

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full-time permanent

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

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Medical Device R&D Engineer

Ballina, Connacht Independent Search Solutions

Posted 5 days ago

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I am keen to speak with R&D Engineers who are looking to further develop their career in the Design and Development of Medical Device Products. Leading R&D Projects at my clients state of the art Medical Device Design Facility, you will work in cross-functional teams based in Ireland and liaise with other R&D Teams Internationally. I currently have a role for a Senior R&D Engineer (€85k+). As well as offering a competitive packages (€ my client has an award-winning culture and at ISS Ltd (Recruitment Agency) we are offering Signing Bonuses ( and Relocations Packages ( - ) for this position APPLY TODAY R&D Engineer / Research & Development / New Product Development / Design Controls / Material Science Engineer / New Product Introduction / R&D / AutoCAD / 3D Modelling / Medical Device / Mayo / Ireland Independent Search Solutions Agency are happy to offer a Relocation Package for Candidates based in Ireland, UK & EU who need to move to the area (County Mayo, Ireland) Job Title: Lead R&D Engineer (Final Stage Development) Location: Co. Mayo Package: Full Time / Permanent (Min, 40% On-Site) k+ Basic Annual Bonus (7.5% - 10%) Health Insurance (VHI) Pension Parking Canteen Paid Annual Leave Relocation Package ( - ) Signing Bonus ( Role: The Lead R&D Engineer will have with extensive research & development experience; and will be capable of utilizing their expertise and skills in the successful development of new products. They will be capable of identifying and investigating new product ideas or technologies and bringing these through a defined technology development process. They will build prototypes, collect user feedback, and conduct experimentation and data analysis to optimize and refine product concepts and perform verification and validation of product designs. You will be capable of serving as a leader in a collaborative and cross functional environment for the successful completion of project goals and will be capable of interfacing with senior management within the organization. Duties: Representing R&D on New Product Development project teams Researching new ideas and technologies/materials and evaluating technology performance and stability Sourcing/selecting materials and components and the evaluation of same Developing product and component specifications to ensure that the product consistently performs to a level which meets the needs of the customer Developing new test methods to characterize and measure the performance of the product Providing technical R&D support to other functions including Global Marketing, Regulatory Affairs, Engineering and Manufacturing Managing project schedules, conducting product and project risk analysis and ensuring successful and timely completion of project activities Working with patent counsel to support patentability/infringement searches and preparation of patent applications Creating relevant design documents including technical reports, drawings, specifications Planning and performing design verification and design validation activities Company: An established Multinational with Manufacturing and R&D facilities on-site in Ireland. Manufacturing a range of disposable Medical Device Products used across the Healthcare Sector. Experience: Third Level Degree (Hon) in Mechanical / Biomedical Engineering 7-8 Years commercial experience in a R&D role (Medical Device Industry) Skills Matrix: Innovative / Creative Thinker; must have a demonstrated ability to conduct exploration of subject areas for novel concepts and approaches Working knowledge of AutoCAD and 3D modelling software Demonstrated analytical problem-solving abilities Demonstrated ability to manage projects including directing the work of others Good team working skills and a high level of enthusiasm and motivation Good working knowledge of medical device quality & regulatory systems and medical device directives If you would like to be considered for this opportunity, follow the links below and send me your CV. Key Words: R&D Engineer / Research & Development / New Product Development / Design Controls / Material Science Engineer / New Product Introduction / R&D / AutoCAD / 3D Modelling / Medical Device / Mayo / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: Medical Device R&D Engineer Research And Development Material Science Engineer New Product Development AutoCAD Prototype Development 3D Modelling Benefits: Annual Bonus / 13th Cheque Group Life Assurance Medical Aid / Health Care Pension Fund Performance Bonus Work From Home Relocation Assistance
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Medical Device R&D Engineer

Ballina, Connacht Independent Search Solutions

Posted 5 days ago

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I am keen to speak with R&D Engineers who are looking to further develop their career in the Design and Development of Medical Device Products. Working on R&D Projects at my clients state of the art Medical Device Design Facility, you will work in cross-functional teams based in Ireland and liaise with other R&D Teams Internationally. I currently have a range of roles from Engineer Level (€65k) to Senior Engineer Level (€5k+). As well as offering competitive packages ( my client has an award-winning culture and at ISS Ltd (Recruitment Agency) we are offering a Signing Bonus ( APPLY TODAY R&D Engineer / Research & Development / Improve Current Product Design / NPD / Design Controls / Material Science Engineer / Hydrophilic Coated Products / Polymer Science / Medical Device / Mayo / Ireland Job Title: R&D Engineer Location: Co. Mayo Package: Full Time / Permanent k - k Basic Annual Bonus (7.5% - 10%) Health Insurance (VHI) Pension Parking Canteen Paid Annual Leave Signing Bonus ( Role: The R&D Engineer is expected to help drive the development and integration of new materials, processes or technologies into new products and processes. You will have a good understanding of medical device design controls, be capable of participating in cross-functional teams and interfacing with colleagues at all levels within the organization while effectively delivering solutions which benefit our customers. Duties: Providing technical support to NPD, Global Marketing, Engineering and Manufacturing Leading or supporting project teams to select and demonstrate the feasibility of alternative materials, processes or technologies for new and existing products Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes Working with cross functional partners to gather stakeholders input and develop plans to ensure requirements are assessed and met by proposed technical solutions Developing protocols and experimental test plans and managing the product build, transportation and storage as well as the execution of testing Conducting statistical analysis of data and developing detailed reports documenting results, conclusions and recommendations Representing the Research & Development function on cross-functional teams throughout the New Product Commercialization process Company: An established Multinational with Manufacturing and R&D facilities on-site in Ireland. Manufacturing a range of disposable Medical Device Products used across the Healthcare Sector. Experience: Third Level Degree (Hon) in Materials / Polymer Science / Mechanical / Biomedical Engineering 3-5 Years commercial experience in a R&D role (Medical Device Industry) An understanding of hydrophilic coatings and related technologies Skills Matrix: Attention to detail and good understanding of design controls and associated documentation A demonstrated track-record of being part of successful cross-functional technical teams Innovative / Creative Thinker; must have a demonstrated ability to conduct exploration of subject areas for novel concepts and approaches Demonstrated analytical problem-solving abilities Demonstrated ability to manage projects including directing the work of others Good team working skills and a high level of enthusiasm and motivation Good working knowledge of medical device quality & regulatory systems and medical device directives Experience of hydrophilic coating technologies, materials science and surface chemistry If you would like to be considered for this opportunity, follow the links below and send me your CV. Other R&D Roles @ ISS Ltd: Snr R&D Team Lead / k+ R&D Project Manager / k+ Key Words: R&D Engineer / Research & Development / Improve Current Product Design / NPD / Design Controls / Material Science Engineer / Hydrophilic Coated Products / Polymer Science / Medical Device / Mayo / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: R&D Engineer Material Science Hydrophilic Coating Technology Design Controls Medical Device R&D Polymer Science R&D Benefits: Annual Bonus / 13th Cheque Group Life Assurance Medical Aid / Health Care Pension Fund Performance Bonus Meal Allowance / Canteen Study Assistance
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Senior Financial Analyst, Medical Device Manufacturing

Galway, Connacht FP&A Senior Finance & Executive Search

Posted 5 days ago

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Our client, a global medical device manufacturer, has created a new Senior Financial Analyst job on their 25 person Finance team in Galway due to continuous growth of their local operations. Its the ideal avenue into the medical device sector if you have strong finance business partnering, budgeting and forecasting experience, or it can be the perfect step-up if you are already working in the medical device industry as the scale and complexity of transactions you will manage will further develop your career. Your work as the Senior Financial Analyst will be value add, among your responsibilities will include: Preparation of the annual budget (AOP) and the 5-year strategic plan for the site in partnership with other members of the FP&A team and heads of department across site Partner with two departments on all their budgeting, forecasting, financial analysis and project accounting, helping non-Finance leaders understand cost and revenue drivers for their departments Overheads budgeting and financial analysis, with over 4,000 employees onsite youll provide deeper insights to senior leadership on spend on FTEs, agency staff, employee benefits, professional contract fees and utilities expenditure This multinational company invest in their people with multiple avenues for career progression including structured promotion opportunities that dont depend on someone higher up moving out of their role and global finance jobs come to the Galway site due to their reputation of excellence and delivery. They are at the cutting edge of innovation exemplified by having a cross-functional A.I. project team who are introducing the latest A.I. technology that automates tasks and the companys share price has grown by 150% in the last five years due to exceeding revenue targets. You will join a high-performing FP&A team who will give you all the support you need to settle into your new job and youll enjoy working with like-minded, capable colleagues. The package on offer is worth €85,000-€90,000 including base salary, annual bonus, full family health insurance, sizeable company pension contribution, share options scheme, hybrid working of 2 days per week and non-monetary benefits of working for a major brand name, significant career progression opportunities and manufacturing operations exposure. Experience To become the Senior Financial Analyst will be a qualified accountant (ACA/ACCA/CIMA) with exposure to financial or commercial analysis which informed business decision making from any sector. Apply today With your latest CV apply now or contact Shane Lynott, Talent Acquisition Manager, via the details in our bio. Skills: Finance Business Partnering Financial Planning & Analysis Benefits: Work From Home
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Electronic Engineer- Medical Device start-up

Galway, Connacht Wallace Myers International

Posted 5 days ago

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Electronic Engineer - Medical Device Are you passionate about developing innovative medical technologies that can change lives? A leading medical device start-up is seeking an Electronic Engineer to join their growing R&D team in the development of a next-generation device. This is a unique opportunity to be a foundational team member in a high-potential, award-winning start-up environment. You will play a pivotal role in enhancing device usability, supporting high-volume manufacturing readiness, and driving the product transition from clinical development to commercial release. Key Responsibilities Design and optimise electrical architecture for wearable medical devices, integrating sensors, microcontrollers, and power circuits. Develop and validate PCB layouts for compact, low-power systems. Manage PCB manufacturing orders and ensure design for manufacturability. Conduct circuit analysis, system testing, and validation in compliance with medical device standards. Implement and refine power management strategies and wireless communication protocols (e.g., WiFi, Bluetooth, cellular). Troubleshoot issues in hardware subsystems during prototyping and production. Collaborate with firmware, mechanical, and clinical teams to deliver integrated product solutions. Maintain accurate documentation, including schematics, test procedures, and compliance reports. Minimum Qualifications Bachelor's degree in Electronic Engineering or equivalent. 5+ years' experience in hardware design for embedded systems. Proven expertise in PCB design/layout, circuit analysis, and low-power electronics. Strong understanding of hardware interfaces (ADC, DAC, GPIO, I2C, SPI, UART). Familiarity with power supply design, battery systems, and wireless communications. Experience with test tools (oscilloscopes, logic analysers, electronic loads). Strong communication skills and ability to work effectively in cross-functional teams. Fluent in English, both written and verbal. Desirable Skills Experience in wearable or medical device development. Knowledge of ECG signal acquisition and conditioning. Familiarity with EMC compliance and safety standards for regulated devices. Experience designing for manufacturability and working with PCB suppliers. Exposure to embedded C/C++ and platforms like Nordic, STM, or ESP32. What's on Offer Competitive salary (details provided during application). Benefits including pension, healthcare, and generous annual leave. Flexible work culture with the opportunity to shape the future of cardiac diagnostics. At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: Medical Device Electronics PCB Design Development Benefits: Work From Home
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Principal Scientist/Engineer Medical Device Development

Dublin, Leinster Life Science Recruitment Ltd

Posted 5 days ago

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Principal Scientist/Engineer Medical Device Development Our Dublin based client are currently recruiting for a highly skilled Principal Scientist/Engineer to join their Device and Product Performance team on a permanent basis. In this role, you will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards. Your expertise will drive technical excellence, innovation, and patient-centric solutions. Responsibilities Provide subject matter expertise to support the development of Combination Products Plan and execute design verification and reliability strategies Be the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements Develop test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system Lead support activities for external and internal audits and inspections as applicable Requirements Degree in Science/Engineering (Masters preferred) 7+ years experience in pharmaceutical and/or medical device development Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage Experience in the development and validation of analytical methods Experienced in application of statistical techniques for data analysis Experience of writing and supporting regulatory submissions Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders Some travel will be required as part of this role For more information, please contact Sinéad Cullen on or Skills: Combination Products Design Verification Analytical Science
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Manager, Medical Device and Combination Product Quality Systems

Sligo, Connacht AbbVie

Posted 6 days ago

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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:
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Manager, Medical Device and Combination Product Quality Systems

Westport, Connacht AbbVie

Posted 6 days ago

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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:
This advertiser has chosen not to accept applicants from your region.

Manager, Medical Device and Combination Product Quality Systems

Dublin, Leinster AbbVie

Posted 6 days ago

Job Viewed

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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:
This advertiser has chosen not to accept applicants from your region.
 

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  64. pets Veterinary
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