Manager, UDI Regulations & Data Strategy

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 seeks a Manager, Global UDI Regulations and Data Strategy to lead the global UDI program across markets, ensuring regulatory compliance and scalable data strategies. The role partners with Regulatory Affairs, IT, Supply Chain, R&D and Commercial teams to execute UDI requirements and improve data capabilities.

The position emphasizes collaboration, regulatory inspections support, and continuous improvement in a regulated medical devices environment, with travel up to 15%.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems or related field.
• Master’s degree in a scientific/technical/business discipline preferred.
• 6–8 years in Quality Assurance, Regulatory Compliance or Technology Quality in regulated industry (medical devices preferred).
• Experience with UDI regulations and global regulatory frameworks (FDA, EU MDR).
• Strong understanding of quality systems, data governance and computerized system validation.
• Proven ability to lead cross-functional, global initiatives in a matrix organization.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Excellent written and verbal communication skills.
• Experience with ERP/PLM and labeling systems is a plus.
• People leadership experience and familiarity with medical device portfolios.
• Knowledge of product lifecycle, global supply chain and labeling processes.

Responsibilities

• Lead and govern the global UDI program with FDA, EU MDR and other regulations.
• Drive strategy for data use within UDI Health Authority records.
• Own UDI processes, controls, and alignment with quality standards.
• Partner with technology and digital teams to meet UDI requirements.
• Lead cross-functional collaboration across Regulatory, Supply Chain, Manufacturing, R&D and Commercial teams.
• Support regulatory inspections and health authority interactions related to UDI compliance.
• Monitor regulatory trends and translate requirements into scalable processes.
• Drive continuous improvement to enhance UDI data utilization and compliance.

Skills

UDI regulations

Global regulatory frameworks

Data governance

Quality systems

Cross-functional leadership

Audits & inspections

Regulatory strategy

Analytical thinking

Project management

Regulatory negotiations

Education

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

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: People Leader

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 Regulations and Data Strategy located in Raritan, NJ, Irvine, CA and Jacksonville, FL! An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The Manager, Global UDI Regulations and Data Strategy is a key leadership role within J&J MedTech, responsible for ensuring global compliance, data strategy, 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, 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 systems.

Key Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
• Drive strategy for functional data use within UDI Health Authority records.
• Own UDI‑related processes, procedures, and controls, ensuring alignment with Technology Quality and quality/regulatory standards.
• Partner with technology and digital teams to ensure capabilities 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 end‑to‑end UDI 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.
• 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 Technology Quality within a regulated industry (medical devices strongly preferred).
• Demonstrated 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.

Equal Opportunity Statement

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

• Agile Decision Making
• Analytics Insights
• Business Alignment
• Developing Others
• Inclusive Leadership
• Leadership
• Monitoring
• Evaluation, and Learning (MEL)
• Organizational Project Management
• Program Management
• Project Management Methodology (PMM)
• Project Management Office (PMO)
• Project Management Tools
• Project Reporting
• Stakeholder Engagement
• Statement of Work (SOW)
• Team Management

Preferred Skills

• Agile Decision Making
• Analytics Insights
• Business Alignment
• Developing Others
• Inclusive Leadership
• Leadership
• Monitoring
• Evaluation, and Learning (MEL)
• Organizational Project Management
• Program Management
• Project Management Methodology (PMM)
• Project Management Office (PMO)
• Project Management Tools
• Project Reporting
• Stakeholder Engagement
• Statement of Work (SOW)
• Team Management

Compensation and Benefits

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

Company Benefits Information

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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/.

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