Manager, Global UDI Process & Governance

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Project/Program Management Group

Project/Program Management

Professional

Irvine, California, United States of America, Jacksonville, Florida, United States of America, Raritan, New Jersey, United States of America

Johnson & Johnson Med Tech is recruiting for a Manager, Global UDI Process and Governance, located in Raritan, NJ, Irvine, CA and Jacksonville, FL!

The Manager, Global UDI Process and Governance is a key leadership role within J&J Med Tech, responsible for ensuring global compliance, process, and execution of Unique Device Identification (UDI) requirements across the J&J Med Tech portfolio. This role partners closely with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data capabilities, process readiness, data governance, and regulatory compliance across global markets.

This position offers the opportunity to lead a globally impactful compliance program that directly supports patient safety, product traceability, and regulatory readiness while shaping scalable, future‑ready UDI processes and capabilities.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

• 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.

• Required:
  
  Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.
• Preferred:
  Master’s degree in a scientific, technical, or business discipline.

• 6–8…