Manager, Global UDI Process & Governance

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

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, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, 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 jnj.com 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.

Job Function

Project/Program Management Group

Job Sub Function

Project/Program Management

Job Category

Professional

All Job Posting Locations

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

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 Manager, Global UDI Process and Governance is a key leadership role within J&J MedTech, responsible for ensuring global compliance, process, and execution of Unique Device Identification (UDI) requirements across the J&J MedTech 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.

About MedTech

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 https://www.jnj.com/medtech

Key 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.

Qualifications

• Education 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.

Experience and Skills Required

• 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.
• Preferred: Experience working with enterprise systems supporting UDI and product data (e.g., ERP, PLM, labeling systems).
• Prior people‑leadership or matrix leadership experience.
• Experience within complex medical device portfolios.
• Familiarity with new product introduction, global supply chain, and labeling processes.
• Change management or continuous improvement experience in regulated environments.

Other Language

English (additional languages a plus).

Travel

Up to 15%, domestic and international.

Certifications

ASQ, RAC, or equivalent quality/regulatory certifications preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills: Agile Decision Making, Agility Jumps, Analytics Insights, Cross-Functional Collaboration, Expectation Management, Leadership, Organizational Project Management, Organizing, Process Improvements, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Quality Assurance (QA), Statement of Work (SOW), Technical Credibility

Salary

The anticipated base pay range for this position is : $102,000.00 - $177,100.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Final Quote

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, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, 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 https://www.jnj.com/.

Do Not Sell or Share My Personal Information Limit the Use of My Personal Information