Global UDI PMO Lead for Regulatory Compliance

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

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