Sr. Manager, UDI PMO
On-site · Raynham, Massachusetts, United States
Job Summary
Lead the UDI Program Management Office (PMO) to govern and execute the Unique Device Identification program globally, ensuring regulatory compliance, data integrity, and inspection readiness across systems and business partners. Drive governance, roadmaps, milestones, and metrics aligned to FDA, EU MDR, and other health authorities; oversee cross-functional collaboration with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams; lead process improvements and standardization using PMO best practices; develop and mentor a PMO/UDI team; monitor regulatory changes and timely implementation; manage risks, dependencies, and resource planning to ensure on-time, compliant delivery. Travel with limited domestic and occasional international assignments. Required: Bachelor’s degree; 8–10 years in regulated industries with PMO leadership; strong knowledge of UDI and quality systems; experience with ERP, labeling, master data, and regulatory systems; PMP/PgMP/Lean Six Sigma preferred. English required; travel as needed. Note: The role may be posted across multiple country sites (US and Ireland in particular).
Required Qualifications
- Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field
- 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry
- Demonstrated leadership of complex, cross-functional programs with global scope
- Strong knowledge of UDI regulations and quality system requirements
- Experience with enterprise systems (ERP, labeling, master data, regulatory systems)
- Excellent communication, risk management, and decision-making skills
Desired Qualifications
- Master’s degree (MS, MBA) in a relevant discipline
- PMO leadership experience within Technology Quality or QA organizations
- PMP, PgMP, Lean Six Sigma or equivalent
- Experience with EU MDR, FDA UDI and global device registration frameworks
- Experience leading cross-functional programs with global scope
- Experience with ERP, labeling, master data, regulatory systems
- Strong communication, risk management, and decision-making skills
- Travel: Limited domestic and occasional international
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