Sr. Manager, UDI PMO

Antler Co; Loughbeg; On-site; EUR 107,000 - 215,000; Full time

Job summary

Johnson & Johnson is recruiting for a Sr. Manager, UDI PMO, based in Ringaskiddy, Ireland and Raynham, MA. The role leads the UDI PMO to ensure global regulatory compliance, data integrity, and inspection readiness across systems and partners.

You will drive governance, strategy, and execution of the UDI program, influencing Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams while developing a high-performing PMO team.

Qualifications

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

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics.
• Provide strategic oversight for UDI-related technology initiatives, ensuring integration across ERP and regulatory 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 and continuous improvement.
• Monitor global regulatory changes related to UDI and assess business impact.
• Manage program risks, dependencies, and resource planning to ensure on-time, compliant delivery.
• Drive process optimization and standardization using PMO best practices.

Skills

UDI regulations

Regulatory knowledge

Cross-functional leadership

Team leadership

PMO leadership

ERP systems

Master data

Quality systems

Education

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

Master’s degree (MS, MBA) preferred

Tools

ERP systems

Labeling systems

Regulatory systems

Job description

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

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

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, located in 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) program. 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.

Key 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 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.

Qualifications

Education

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

Experience and Skills

• 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).
• 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 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 device manufacturing or orthopedic products.
• Excellent communication, risk management, and decision‑making skills.

Other

• Language: English (required).
• Travel: Limited domestic 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, career and 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.

Required 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

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 :

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