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.
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.
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
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
