Sr. Manager, UDI PMO
On-site · Raynham, Massachusetts, United States or Ringaskiddy, Munster, Ireland
Job Summary
Sr. Manager, UDI PMO leads the strategic planning, governance, and execution of the Unique Device Identification (UDI) program across global sites. Drives regulatory compliance, data integrity, and inspection readiness while enabling scalable UDI processes across systems and business partners. Provides cross-functional leadership, develops a team of PMO/UDI professionals, and ensures on-time, compliant delivery. Partners with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams; governs roadmaps, milestones, risk management, and audit support; oversees documentation, change control, and risk management to enable patient safety and regulatory outcomes. Requires strong leadership, communication, and program-management capabilities; experience with EU MDR, FDA UDI, and global device-registration frameworks and a background in medical devices is preferred.
Required Qualifications
- Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field
- Experience: typically 8–10 years in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred)
- Strong knowledge of UDI regulations and quality system requirements
- Experience leading cross-functional programs with global scope
- Experience with ERP, labeling, master data, regulatory systems
- PMP, PgMP, Lean Six Sigma or equivalent (preferred)
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