Manager, Global UDI
$117,000–$234,000 year
Hybrid · Raynham, Massachusetts, United States or West Chester, Pennsylvania, United States
Job Summary
Lead and govern the global UDI program across DePuy Synthes’ orthopedic portfolio, ensuring compliance with FDA, EU MDR, and other applicable UDI regulations. Partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance across global markets. Drive end-to-end UDI governance, data management, change control, and audits; support regulatory inspections; translate evolving requirements into scalable processes; coach and develop team members; travel up to 10–20%.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field
- 6–8 years of relevant experience in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry (medical devices strongly preferred)
- Demonstrated experience with UDI regulations and global regulatory frameworks (FDA, EU MDR)
- Strong knowledge of quality systems, data governance, and computerized system validation
- Proven ability to lead cross-functional, global initiatives in a matrixed organization
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