Manager, Global UDI Process & Governance (MedTech)

Location: Raritan, New Jersey; Irvine, California; or Jacksonville, Florida, United States. Travel up to 15%, including domestic and international travel.

Base pay: $102,000–$177,100 per year.

Company

Johnson & Johnson MedTech develops innovative, less invasive, and personalized medical treatments at the intersection of biology and technology.

What you will do

• Lead and govern the global Unique Device Identification program across the MedTech portfolio.
• Ensure compliance with FDA, EU MDR, and other international UDI regulations.
• Own UDI processes, procedures, controls, data governance, and periodic compliance reviews.
• Partner with Regulatory Affairs, IT, Supply Chain, Manufacturing, R&D, and Commercial teams.
• Establish and maintain technology and digital capabilities supporting UDI processes.
• Support regulatory inspections, internal audits, health authority interactions, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.
• 6–8 years of experience in Quality Assurance, Regulatory Compliance, or process engineering in a regulated industry; medical device experience is strongly preferred.
• Proven experience with UDI regulations and global regulatory frameworks, including FDA and EU MDR.
• Understanding of quality systems, data governance, and computerized system validation.
• Experience leading cross-functional global initiatives in a matrixed organization and supporting audits or regulatory inspections.
• English required; additional languages are a plus.

Nice to have

• Master’s degree in a scientific, technical, or business discipline.
• Experience with ERP, PLM, labeling, or other enterprise systems supporting UDI and product data.
• People-leadership or matrix-leadership experience.
• Experience with medical device portfolios, new product introduction, global supply chain, labeling, change management, or continuous improvement.
• ASQ, RAC, or equivalent quality/regulatory certification.

Culture & Benefits

• Inclusive work environment focused on employee diversity, dignity, and merit.
• Eligibility for the company pension and 401(k) savings plans.
• Eligibility for a long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time-off.
• Inclusive interview accommodations are available for applicants with disabilities.