Global UDI PMO Lead — Reg & Quality Excellence

Brighter Signals

Raynham (MA)

On-site

USD 122,000 - 213,000

Full time

8 days ago

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Job summary

The Sr Manager, UDI PMO leads strategic planning, governance, and execution of the UDI program within Strategic Governance and Insights, ensuring global regulatory compliance and data integrity. Role offers high visibility and cross-functional leadership across DePuy Synthes.

You will influence patient safety and regulatory outcomes across the portfolio, driving scalable UDI processes and standards globally.

Qualifications

Bachelor’s degree in Engineering, IS, Life Sciences, or related field required.
8–10 years in Quality, Regulatory, Technology, or Program Management in a regulated industry (medical device preferred).
Experience leading global, cross-functional programs with PMO experience.
Strong knowledge of UDI regulations and quality system requirements.

Responsibilities

Lead UDI PMO with governance, roadmaps, milestones, and metrics.
Oversee UDI-related technology initiatives 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 with documentation, risk management, change control, and audit support processes.
Lead and develop a PMO/UDI team, fostering accountability and quality culture.
Monitor regulatory changes related to UDI and implement timely updates.
Manage program risks, dependencies, and resource planning for on-time delivery.
Drive process improvement using PMO principles and quality systems.