Global UDI & Regulatory Governance Lead

Johnson Johnson; Raritan (NJ); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation hours

Sick time

Holiday pay

Parental Leave

Job summary

Johnson & Johnson MedTech is recruiting for a Manager, Global UDI Process and Governance, located in Raritan, NJ, Irvine, CA and Jacksonville, FL. The role leads the global UDI program to ensure compliance with FDA, EU MDR and international regulations, partnering with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams.

This position offers the opportunity to shape scalable UDI processes, drive data governance, support regulatory inspections, and influence quality management across

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.
• 6–8 years of QA, Regulatory Compliance, or process engineering in a regulated industry.
• Experience with UDI regulations and global regulatory frameworks (FDA, EU MDR).
• Strong knowledge of quality systems and data governance.
• Ability to lead cross-functional, global initiatives in a matrixed organization.

Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
• Drive governance for functional 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 ensure capabilities to execute UDI related processes are established and maintained to meet UDI requirements.
• 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 business and quality management system processes.
• Drive continuous improvement initiatives to enhance UDI data utilization, efficiency, and compliance sustainability including ownership of required periodic reviews to demonstrate effective processes and execution to compliance requirements.
• Provide coaching and leadership to team members and stakeholders to strengthen UDI knowledge and capabilities across the organization.

Skills

UDI regulations

Regulatory compliance

Quality systems

Cross-functional leadership

Data governance

Education

Bachelor's degree

Master's degree

Tools

ERP

PLM

Labeling systems

Enterprise systems

Job description

Johnson & Johnson MedTech is recruiting for a Manager, Global UDI Process and Governance, located in Raritan, NJ, Irvine, CA and Jacksonville, FL. The role leads the global UDI program to ensure compliance with FDA, EU MDR and international regulations, partnering with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams.

This position offers the opportunity to shape scalable UDI processes, drive data governance, support regulatory inspections, and influence quality management across