Global UDI Process & Governance Lead

Johnson Johnson; Irvine (CA); On-site; USD 102,000 - 177,000; Full time

Benefits offered by this job

Vacation hours

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson MedTech is seeking a Manager, Global UDI Process and Governance to lead a globally impactful compliance program spanning FDA/EU MDR regulations. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial to build scalable UDI processes and data governance across multiple sites including Irvine, CA and Raritan, NJ.

This role focuses on ensuring patient safety, product traceability, and regulatory readiness while advancing continuous improvement in UDI data

Qualifications

• 6–8 years of proven experience in Quality Assurance, Regulatory Compliance, or process engineering within a regulated industry (medical devices strongly preferred).
• Proven experience with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).
• Solid understanding of quality systems, data governance, and computerized system validation.
• Proven ability to lead cross-functional, global initiatives in a matrixed organization.
• Experience supporting audits and/or regulatory inspections.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Excellent written and verbal communication skills.

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

Quality Assurance

Regulatory Compliance

Process Engineering

UDI Regulations

Cross-functional Leadership

Education

Bachelor's degree in Engineering, Life Sciences, Information Systems

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 globally impactful compliance program spanning FDA/EU MDR regulations. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial to build scalable UDI processes and data governance across multiple sites including Irvine, CA and Raritan, NJ.

This role focuses on ensuring patient safety, product traceability, and regulatory readiness while advancing continuous improvement in UDI data