10 Johnson Johnson jobs in Ireland
Senior Regulatory Affairs Program Lead - Johnson & Johnson MedTech

Posted 8 days ago
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Regulatory Affairs Group
**Job Sub** **Function:**
Regulatory Product Submissions and Registration
**Job Category:**
Professional
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**We are searching for the best talent as Senior Regulatory Affairs Program Lead to be in Galway, Ireland.**
**Purpose of the role:**
The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches and ongoing regulatory compliance.
**What you will be doing?**
+ Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
+ Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (e.g. represents Regulatory in the complaint handling and field action process).
+ Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision.
+ Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required.
+ Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes
+ Ensures compliance with regulatory agency regulations and interpretations.
+ Prepares responses to regulatory agencies' questions and other correspondence.
+ Provides regulatory advice to project teams.
+ Guides conformance with applicable regulations in product development, support of claims and label content.
+ Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
+ Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies.
+ Provides Regulatory Affairs support during internal and external audits.
+ Represents Regulatory Affairs on cross-functional project teams.
**What you will bring:**
+ Strong experience in the medical device industry, with some experience in a position in regulatory affairs or related/equivalent field.
+ Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
+ Experience of inspection by an external agency, such as the FDA / BSI
+ Ability to work well under deadlines and pressure.
+ Demonstrated track record in:
+ Submission of licenses and authorizations for the maintenance of existing products
+ International registrations and dossiers
+ Execution of regulatory strategies that align with business deliverables.
**Required experience:**
+ Knowledge/working experience of the European Medical Device Directive/Regulation (EU MDD 93/42/EEC and EU MDR 2017/745), FDA's 21 CFR Part 812 (Investigational Device Exemption), 21 CFR Part 807 (Premarket Notifications), 21 CFR Part 814 (Premarket Approval), and relevant European and US regulations and standards, including Quality System requirements, such as 21 CFR Part 820 (Quality System Regulation), EN ISO 13485, etc.
+ Knowledge of other applicable medical device regulations, e.g. Brazilian, Canadian, Australian, Japanese, Korean, etc., advantageous.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Excellent written and communication skills, fluency in English.
+ Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both Cerenovus and their customers.
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
Posted 2 days ago
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Job Description
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)Medical Device Product Specialist
Posted 19 days ago
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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
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Occupational Health Nurse Medical Device
Posted 4 days ago
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Medical Device R&D Engineer
Posted today
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Associate Director - R&D Engineering (Medical Device)
Posted today
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Associate director - r&d engineering (medical device)
Posted today
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Manager, Medical Device and Combination Product Quality Systems

Posted 8 days ago
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Job 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:
Manager, Medical Device and Combination Product Quality Systems

Posted 8 days ago
Job Viewed
Job 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:
Manager, Medical Device and Combination Product Quality Systems

Posted 8 days ago
Job Viewed
Job 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: