Global UDI PMO Leader

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 122,000 - 245,000; Full time

Job summary

Johnson & Johnson DePuy Synthes is seeking a Sr. Manager, UDI PMO to lead the strategic planning, governance, and execution of the global Unique Device Identification program.

You will partner with Quality, Regulatory, IT, and Supply Chain to ensure regulatory compliance, data integrity, and inspection readiness across systems and partners. The role requires 8–10 years in a regulated setting, strong PMO leadership, and expertise in UDI regulations and enterprise systems.

Qualifications

• 8–10 years 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.

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

UDI regulations

ERP systems

Cross-functional leadership

Data integrity

Program management

Education

Bachelor’s degree

Master’s degree

Tools

ERP systems

Labeling systems

Master data systems

Regulatory systems

Job description

Johnson & Johnson DePuy Synthes is seeking a Sr. Manager, UDI PMO to lead the strategic planning, governance, and execution of the global Unique Device Identification program.

You will partner with Quality, Regulatory, IT, and Supply Chain to ensure regulatory compliance, data integrity, and inspection readiness across systems and partners. The role requires 8–10 years in a regulated setting, strong PMO leadership, and expertise in UDI regulations and enterprise systems.