Sr. Manager, UDI PMO

6149-DePuy Synthes Products Inc. Legal Entity; Raynham (MA); On-site; USD 122,000 - 245,000; Full time

Job summary

Johnson & Johnson in Raynham, MA and Ringaskiddy, Ireland seeks a Sr. Manager, UDI PMO to lead governance, roadmaps, and cross‑functional delivery of the UDI program.

You will align regulatory requirements with global processes and drive data integrity, inspection readiness, and scalable UDI workflows. This high‑visibility role partners with Quality, Regulatory Affairs, IT, Supply Chain, and Commercial teams, builds and mentors a PMO team, and influences global health authority outcomes while

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field.
• Preferred Master’s degree (MS, MBA).
• 8–10 years in Quality, Regulatory, Technology, or Program Management in regulated industry.
• Experience leading global, cross-functional programs.
• Strong knowledge of UDI regulations and quality system requirements.
• Experience with ERP, labeling, master data, regulatory systems.

Responsibilities

• Lead the UDI PMO, establishing governance, roadmaps, milestones, and metrics.
• Provide strategic oversight for UDI-related technology initiatives across systems.
• Collaborate with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams.
• Maintain inspection readiness with robust documentation and risk management.
• Lead and develop a team of PMO and UDI professionals.
• Monitor regulatory changes and implement timely updates.
• Manage risks, dependencies, and resource planning for on-time delivery.
• Drive process optimization and standardization using PMO best practices.

Skills

PMO leadership

Regulatory compliance

Global program management

Cross-functional leadership

Quality systems

UDI regulations

Enterprise systems

Communication

Risk management

Decision making

Education

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

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

Tools

ERP

Labeling systems

Master data management

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: 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:
  • Required: 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.
• 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

Salary

The anticipated base pay range for this position is : 1,22,000.00 - 2,45,000.00 USD

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

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 https://www.jnj.com/.