Regulatory Affairs Medical Devices jobs
- J&JCork, County CorkAd
- Demonstrated experience managing initiatives in regulatory affairs, supply chain, labeling, or digital transformation.
- Experience with change control processes.
- Analog DevicesLimerick, County Limerick
- Certification in regulatory compliance or CE marking.
- Experience with international regulatory standards beyond the EU (e.g., UL, FCC).
- Abbott LaboratoriesKilkenny, County Kilkenny
- Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and…
- Abbott LaboratoriesClonmel, County Tipperary
- Innovative and emerging medical device technologies.
- Contribute to the design and development of innovative medical devices.
- Polymer and metal 3D printing.
- AbbVieSligo, County Sligo
- Proven track record in audit management and regulatory interaction management.
- Liaise with AbbVie Product Quality, S&T and Regulatory affairs function in…
- View all AbbVie jobs - Sligo jobs - Quality Assurance Manager jobs in Sligo, County Sligo
- Salary Search: QA Operations Manager salaries in Sligo, County Sligo
- See popular questions & answers about AbbVie
- ViatrisNorthern Cross, County Dublin
- Support development and monitoring of regulatory process adherence oversight.
- Ensure all documentation is audit ready, traceable, accessible, and compliant with…
- ViatrisNorthern Cross, County Dublin
- Knowledge of Design Controls, Quality Management Systems (QMS), and medical device/combination product regulatory requirements.
- View all Viatris jobs - Northern Cross jobs - Scientist jobs in Northern Cross, County Dublin
- Salary Search: Device Development Assurance Scientist salaries
- See popular questions & answers about Viatris
- ViatrisNorthern Cross, County Dublin
- Partners with corporate affairs, government affairs, and other local policy leaders to achieve business policy objectives.
- ViatrisNorthern Cross, County Dublin
- Monitor regulatory trends and identify industry “best practices” for relevant medical device and combination products and governing QMS.
- Sanmina CorporationFermoy, County Cork
- To formulate and execute validation plans for medical devices.
- Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the…
- FP&ACounty Westmeath
- Work across a variety of projects and departments including contributing to sustainability impact reporting on emissions reductions, IT projects, regulatory…
- View all FP&A jobs - County Westmeath jobs - Financial Analyst jobs in County Westmeath
- Salary Search: Financial Analyst, Midlands salaries
- FP&ACounty Westmeath
- Work across a variety of projects and departments including contributing to sustainability impact reporting on emissions reductions, IT projects, regulatory…
- View all FP&A jobs - County Westmeath jobs - Financial Analyst jobs in County Westmeath
- Salary Search: Financial Analyst, Midlands salaries
- Zimmer BiometGalway, County Galway
- Lead the development, optimisation and validation of scalable additive manufacturing processes for regulated medical device production.
- Zimmer BiometShannon, County Clare
- A minimum of 2 years of experience in medical device industry preferred.
- Understanding and ensuring compliance with relevant regulations and standards such as…
- View all Zimmer Biomet jobs - Shannon jobs
- Salary Search: Supplier Quality Engineer salaries
- See popular questions & answers about Zimmer Biomet
- Takeda PharmaceuticalDublin, County Dublin
- Proactively monitor regulatory changes in the EEA and updates, and supports necessary adjustments to maintain regulatory compliance across Business Units for…
- Avery DennisonLongford, County Longford
- Knowledge of medical device manufacturing, GMP environments, lean tools, and DMAIC processes.
- Our commitment to science and innovation alongside our passion to…
- View all Avery Dennison jobs - Longford jobs
- Salary Search: Process Engineer salaries in Longford, County Longford
- See popular questions & answers about Avery Dennison
Project Manager, Digital Labeling
Job details
Job type
Full job description
Project Manager, Digital Labeling
Location: Cork, Ireland OR Beerse, Belgium
Working pattern: Mainly remote with some onsite presence required
Duration: 12 months ongoing
Imagine your next project leading the end-to-end deployment of Digital Labeling across designated Johnson & Johnson Innovative Medicine countries and markets, driving complex cross-functional global and regional supply chain and digital transformation initiatives.
Scope of Services: the Project Manager will lead the end-to-end deployment of Digital Labeling across designated J&J Innovative Medicine countries and markets.
Key Stakeholders: the contractor will work closely with and coordinate activities across the following functions: MSAT (Manufacturing Science & Technology), Deliver, Plan and Regional Demand & Supply, Product Artwork, Master Data, Regulatory Affairs, Quality, T&LC (Traceability & Labeling Control - Enterprise team), and Finance.
roles and responsibilities.
-
Develop and maintain the overall project plan, timeline, milestones, dependencies, risks, and mitigation strategies.
-
Coordinate and lead the Digital Labeling Core Team and governance meetings.
-
Drive execution activities across all project workstreams and ensure timely completion of deliverables.
-
Establish clear accountability and ownership for project activities across functions.
-
Monitor project health and proactively identify, escalate, and resolve risks, issues, and roadblocks.
-
Ensure alignment between global program requirements and country-specific implementation needs.
-
Facilitate decision-making and stakeholder engagement throughout the project lifecycle.
-
Support change management, communications, and readiness activities as required.
-
Schedule, facilitate, and lead recurring core team meetings.
-
Own and coordinate country-specific change control activities.
-
Prepare meeting agendas, project updates, and status reports.
-
Document decisions, actions, risks, and dependencies.
-
Follow up on action items and ensure timely closure.
-
Escalate issues to governance forums when necessary.
-
Drive cross-functional collaboration to maintain project momentum and delivery commitments.
-
Ensure implementation activities comply with applicable regulatory, quality, and data integrity requirements.
-
Deliver key deliverables: Comprehensive project plan and implementation roadmap.
-
Deliver key deliverables: Project governance structure and communication plan.
-
Deliver key deliverables: Weekly and monthly project status reports.
-
Deliver key deliverables: Risk, issues, dependency, lesson learned management logs.
-
Deliver key deliverables: Meeting agendas, minutes, and action trackers.
-
Deliver key deliverables: Country implementation readiness assessments.
-
Deliver key deliverables: Go-live preparation and execution support.
-
Deliver key deliverables: Post-implementation stabilization and transition documentation.
how to succeed.
-
Minimum 5 - 8 years of project management experience, preferably within the pharmaceutical, medical device, or healthcare industry.
-
Proven experience leading complex, cross-functional global or regional programs.
-
Demonstrated experience managing initiatives in regulatory affairs, supply chain, labeling, or digital transformation.
-
Strong stakeholder management, communication, and facilitation skills.
-
Experience working with multinational teams and global deployments.
-
PMP, or equivalent project management certification preferred.
-
Experience with change control processes.
-
Experience with quality system.
benefits.
This role offers a very competitive hourly rate. This contract will run for 12 months ongoing (October 2026 – December 2027, with the possibility of extension based on project needs and performance)
you are welcome here.
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
application process.
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.
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 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”.