Sr. Manager, UDI PMO

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 a 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.