Sr Manager Global Unique Device Identifier (UDI) Program Management

Biopharma Asia; Cork; Hybrid; EUR 85,000 - 146,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson in Cork, Ireland, seeks Sr Manager, UDI PMO to lead the global Unique Device Identifier program across REG/QA and IT interfaces. You will set governance, roadmaps, and milestones, ensuring regulatory compliance and audit readiness while enabling scalable UDI processes across ERP, labeling, and master data.

You will manage a PMO team, drive cross-functional execution with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial units, and monitor regulatory changes to

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field is required.
• Master’s degree (MS, MBA) in a relevant discipline is preferred.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
• Demonstrated leadership of complex, cross‑functional programs with global scope.

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
• Provide strategic oversight for UDI‑related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission system.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end‑to‑end UDI compliance and execution.
• Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.
• Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
• Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
• Manage program risks, dependencies, and resource planning to ensure on‑time, compliant delivery of UDI initiatives.
• Drive process optimization and standardization using PMO best practices and quality system principles.

Skills

Leadership

Cross-functional collaboration

PMO leadership

Regulatory knowledge

Stakeholder influence

Education

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field

Master’s degree (MS, MBA) in a relevant discipline

Tools

ERP systems

Labeling systems

Master data systems

Regulatory submission systems

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Project/Program Management Group

Job Sub Function:

Project/Program Management

Job Category:

Professional

All Job Posting Locations:

Dublin, Ireland, Ringaskiddy, Cork, Ireland

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Sr Manager Global Unique Device Identifier (UDI) Program Management, located in one of the following locations:

Raynham, MA

Bridgewater, NJ

Cork, Ireland

Dublin, Ireland

Palm Beach Gardens, FL

Warsaw, IN

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-102789

Ireland – Requisition Number: R-107632

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose:

The Sr. Manager, UDI PMO leads the strategic planning, governance, and execution of the Unique Device Identification (UDI) program within Strategic Governance and Insights, This role is critical to ensuring global regulatory compliance, data integrity, and sustained inspection readiness while enabling efficient, scalable UDI processes across systems and business partners. The role offers high visibility, cross‑functional leadership, and the opportunity to directly impact patient safety and regulatory outcomes across the DePuy Synthes portfolio.

You will be responsible for:

Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).

Provide strategic oversight for UDI‑related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission system

Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end‑to‑end UDI compliance and execution.

Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.

Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.

Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.

Manage program risks, dependencies, and resource planning to ensure on‑time, compliant delivery of UDI initiatives.

Drive process optimization and standardization using PMO best practices and quality system principles.

Qualifications / Requirements:

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field is required. Master’s degree (MS, MBA) in a relevant discipline is preferred.

8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).

Demonstrated leadership of complex, cross‑functional programs with global scope.

Strong knowledge of UDI regulations and quality system requirements.

Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).

Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Preferred:

Experience supporting regulatory inspections and health authority audits related to UDI or data integrity.

PMO leadership experience within Technology Quality and Regulatory organizations.

Familiarity with EU MDR, FDA UDI, and global device registration frameworks.

Experience driving process improvement initiatives (Lean, Six Sigma).

Background in medical device manufacturing or orthopedic products.

Excellent communication, risk management, and decision‑making skills.

Certifications: PMP, PgMP, Lean Six Sigma, or equivalent.

Other:

Proficiency (oral & written) in the English language is required.

Up to 25% domestic and occasional international travel may be required.

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position.

#LI-Hybrid

Preferred Skills:

Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross-Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical Credibility

The anticipated base pay range for this position is:

€85,000.00 - €146,050.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.