Global UDI PMO Lead for Regulatory Excellence

Johnson & Johnson Innovative Medicine; Ringaskiddy; On-site; EUR 107,000 - 215,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks a Sr. Manager, UDI PMO, to lead the global UDI program across Raynham and Ringaskiddy, aligning governance with regulatory requirements and ensuring patient safety.

The role drives cross‑functional collaboration with Quality, Regulatory, IT, and Supply Chain to deliver scalable, compliant UDI processes and robust data integrity across systems. This senior PMO position offers high visibility and the opportunity to influence regulatory outcomes

Qualifications

• 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).

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements.
• 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

PMO leadership

Regulatory knowledge

Stakeholder management

Cross-functional leadership

Risk management

Education

Bachelor's degree in Engineering/IS/Life Sciences/Quality

Master's degree (MS/MBA)

Tools

ERP systems

Labeling systems

Master data

Regulatory submission systems

Job description

Johnson & Johnson Innovative Medicine seeks a Sr. Manager, UDI PMO, to lead the global UDI program across Raynham and Ringaskiddy, aligning governance with regulatory requirements and ensuring patient safety.

The role drives cross‑functional collaboration with Quality, Regulatory, IT, and Supply Chain to deliver scalable, compliant UDI processes and robust data integrity across systems. This senior PMO position offers high visibility and the opportunity to influence regulatory outcomes