Sr. Manager, UDI PMO
Johnson & Johnson · Raynham, MA +4 more
RegulatoryFull-timeCompany career page
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Role summary
Senior Manager leading the Unique Device Identification (UDI) Program Management Office at DePuy Synthes, responsible for strategic planning, governance, and execution of UDI compliance initiatives across global regulatory frameworks. This role ensures regulatory compliance, data integrity, and inspection readiness while managing cross-functional teams and technology integration.
What they're looking for
- Bachelor's degree in Engineering, Information Systems, Life Sciences, Quality, or related field
- 8–10 years progressive experience in Quality, Regulatory, Technology, or Program Management in regulated industries
- Demonstrated leadership of complex, cross-functional programs with global scope
- Strong knowledge of UDI regulations and quality system requirements
- Experience with enterprise systems including ERP, labeling, master data, and regulatory platforms
- Proven ability to lead teams and influence stakeholders in matrixed environments
- Fluent in English
What you'll be doing
- Lead UDI PMO, establishing governance, roadmaps, milestones, and performance metrics aligned to FDA, EU MDR, and other regulatory requirements
- Provide strategic oversight of UDI technology initiatives and ensure integration across systems
- Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams on end-to-end UDI compliance
- Maintain inspection readiness through documentation, risk management, change control, and audit support
- Lead and develop PMO and UDI professionals; monitor regulatory changes and drive timely implementation
Privacy & handoff
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