Sr. Manager, UDI PMO

Johnson & Johnson Innovative Medicine; Ringaskiddy; On-site; EUR 107,000 - 215,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Sr. Manager, UDI PMO, to lead the global UDI program across Raynham and Ringaskiddy, aligning governance with regulatory requirements and ensuring patient safety.

The role drives cross‑functional collaboration with Quality, Regulatory, IT, and Supply Chain to deliver scalable, compliant UDI processes and robust data integrity across systems. This senior PMO position offers high visibility and the opportunity to influence regulatory outcomes

Qualifications

• Typically 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).

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements.
• Provide strategic oversight for UDI-related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
• 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

PMO leadership

Regulatory knowledge

Stakeholder management

Cross-functional leadership

Risk management

Education

Bachelor's degree in Engineering/IS/Life Sciences/Quality

Master's degree (MS/MBA)

Tools

ERP systems

Labeling systems

Master data

Regulatory submission systems

Job description

Job Function:

Project/Program Management Group

Job Sub Function:

Project/Program Management

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for a(n) Sr. Manager, UDI PMO,locatedin Raynham, MA and Ringaskiddy, Ireland.

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):

Raynham, MA (USA) - Requisition Number: 078354

Loughbeg, Ringaskiddy - Requisition Number: 081276

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

The Sr. Manager, UDI PMO leads the strategic planning, governance, and execution of the Unique Device Identification (UDI) programThisrole 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‑functionalleadership, and the opportunity to directlyimpactpatient safety and regulatory outcomes across the DePuy Synthes portfolio.

Key Responsibilities

• Lead the UDI Program Management Office (PMO), establishinggovernance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
• Provide strategic oversight forUDI‑relatedtechnology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to driveend‑to‑endUDI compliance and execution.
• Ensureinspectionreadiness bymaintainingrobust 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, drivingtimelyimplementation of required updates.
• Manage program risks, dependencies, and resource planning to ensureon‑time, compliant delivery of UDI initiatives.
• Drive process optimization and standardization using PMO best practices and quality system principles.

Qualifications

Education:

• Required:Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field.
• Preferred: Master’s degree (MS, MBA) in a relevant discipline.

Experience and Skills:

Required:

• Typically8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
• Demonstrated leadership of complex,cross‑functionalprograms with global scope.
• Strong knowledge of UDI regulations and quality system requirements.
• Experience working with enterprise systems (ERP, labeling, master data, regulatorysystems).
• Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Preferred:

• Experience supporting regulatory inspections and healthauthorityaudits related to UDI or data integrity.
• PMO leadership experience within Technology Quality or QA organizations.
• Familiarity with EU MDR, FDA UDI, and global device registration frameworks.
• Experience driving process improvement initiatives (Lean, Six Sigma).
• Background in medical devicemanufacturing ororthopedic products.
• Excellent communication, risk management, anddecision‑makingskills.

Other:

• Language: English (required).
• Travel:Limiteddomestic and occasional international.
• Certifications (Preferred): PMP,PgMP, Lean Six Sigma, or equivalent.

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visit www.careers.jnj.com.

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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

1,22,000.00 - 2,45,000.00 USD Annual

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth / adoption / foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits