Global UDI PMO Lead - Regulatory Compliance & Strategy

Brighter Signals; Florida; On-site; USD 122,000 - 213,000; Full time

Job summary

The Sr Manager, UDI PMO at Johnson & Johnson leads the strategic planning, governance, and execution of the Unique Device Identification program within Strategic Governance and Insights. This role ensures global regulatory compliance, data integrity, and inspection readiness across the DePuy Synthes portfolio.

You will partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end UDI execution, manage risks, mentor PMO staff, and monitor regulatory changes.

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field required.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or PM within a regulated industry.
• Demonstrated leadership of complex cross-functional programs with global scope.
• Strong knowledge of UDI regulations and quality system requirements.

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.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Quality systems

Program management

ERP systems

Education

Bachelor’s degree in a relevant field

Master’s degree preferred

Tools

ERP systems

Labeling systems

Master data systems

Job description

The Sr Manager, UDI PMO at Johnson & Johnson leads the strategic planning, governance, and execution of the Unique Device Identification program within Strategic Governance and Insights. This role ensures global regulatory compliance, data integrity, and inspection readiness across the DePuy Synthes portfolio.

You will partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end UDI execution, manage risks, mentor PMO staff, and monitor regulatory changes.