Global UDI Governance Lead

6209-Medical Devices & Diagnostics Global Services, LLC Legal Entity; Raritan Township (ND); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Manager, Global UDI Process and Governance, to lead a global program ensuring UDI compliance across markets. Located in multiple sites, the role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial to shape scalable UDI data capabilities and governance.

The role requires 6–8 years in QA/regulatory roles within medical devices, strong data governance, and experience with FDA/EU MDR frameworks. Travel up to 15% is possible.

Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field.
• Master’s degree in a scientific, technical, or business discipline preferred.
• 6–8 years of experience in Quality Assurance, Regulatory Compliance, or process engineering in a regulated industry (medical devices preferred).
• Experience with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).

Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other international UDI regulations.
• Drive governance for data owners connected to UDI Health Authority records.
• Own UDI-related processes, procedures, and controls, ensuring alignment with quality/regulatory standards.
• Partner with technology and digital teams to establish and maintain capabilities to execute UDI processes.
• Lead cross-functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure governance is met with data and execution.
• Support and participate in regulatory inspections, internal audits, and health authority interactions related to UDI compliance.
• Monitor global regulatory trends and translate new or evolving UDI requirements into scalable processes and quality management systems.
• Drive continuous improvement initiatives to enhance UDI data utilization, efficiency, and compliance maintenance including periodic reviews.
• Provide coaching and leadership to team members to strengthen UDI knowledge across the organization.

Skills

Regulatory compliance

UDI regulations

Cross-functional leadership

Data governance

Quality systems

Audit support

Regulatory inspections

Stakeholder collaboration

Project management

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s degree preferred

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson MedTech is seeking a Manager, Global UDI Process and Governance, to lead a global program ensuring UDI compliance across markets. Located in multiple sites, the role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial to shape scalable UDI data capabilities and governance.

The role requires 6–8 years in QA/regulatory roles within medical devices, strong data governance, and experience with FDA/EU MDR frameworks. Travel up to 15% is possible.