Global UDI PMO Lead - Regulatory & Quality

Brighter Signals; Warsaw (IN); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead governance, strategy, and execution of the UDI program across the DePuy Synthes portfolio. You will drive regulatory compliance, data integrity, and inspection readiness with cross‑functional teams in a fast‑paced medical device environment.

The role offers high visibility, leadership of PMO professionals, and exposure to ERP, labeling, and master data systems while coordinating with Quality, Regulatory, and IT to enable global UDI

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field.
• Master’s degree (MS, MBA) preferred.
• 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 with enterprise systems (ERP, labeling, master data, regulatory systems).
• Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

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

Regulatory knowledge

Cross-functional leadership

Program management

ERP knowledge

Education

Bachelor’s degree

Master’s degree preferred

Tools

ERP systems

Labeling systems

Regulatory systems

Job description

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead governance, strategy, and execution of the UDI program across the DePuy Synthes portfolio. You will drive regulatory compliance, data integrity, and inspection readiness with cross‑functional teams in a fast‑paced medical device environment.

The role offers high visibility, leadership of PMO professionals, and exposure to ERP, labeling, and master data systems while coordinating with Quality, Regulatory, and IT to enable global UDI