Job Description
DePuy Synthes is recruiting for a Senior Manager, UDI PMO, located in Raynham, MA and Ringaskiddy, Ireland.
Job Locations: Palm Beach Gardens, Florida; Raynham, Massachusetts; Ringaskiddy, Cork; Warsaw, Indiana; West Chester, Pennsylvania.
Key Responsibilities
Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
Provide strategic oversight for UDI‑related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end‑to‑end UDI compliance and execution.
Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.
Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
Manage program risks, dependencies, and resource planning to ensure on‑time, compliant delivery of UDI initiatives.
Drive process optimization and standardization using PMO best practices and quality system principles.
Qualifications
Education:
Required: Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field.
Preferred: Master’s degree (MS, MBA) in a relevant discipline.
Experience and Skills:
Typically 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
Demonstrated leadership of complex, cross‑functional programs with global scope.
Strong knowledge of UDI regulations and quality system requirements.
Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).
Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.
Preferred:
Experience supporting regulatory inspections and health authority audits related to UDI or data integrity.
PMO leadership experience within Technology Quality or QA organizations.
Familiarity with EU MDR, FDA UDI, and global device registration frameworks.
Experience driving process improvement initiatives (Lean, Six Sigma).
Background in medical device manufacturing or orthopedic products.
Excellent communication, risk management, and decision‑making skills.
Other:
Language: English (required).
Travel: Limited domestic and occasional international.
Certifications (Preferred): PMP, PgMP, Lean Six Sigma, or equivalent.
Pay Range
1,220,000.00 – 2,450,000.00 USD Annual
Equal Opportunity
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
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