Manager, Global UDI Process & Governance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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.

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 futureready UDI processes and capabilities.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 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 UDIrelated 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 crossfunctional 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: Bachelors degree in Engineering Life Sciences Information Systems or a related field.
• Preferred: Masters degree in a scientific technical or business discipline.

Experience and Skills

Required:

• 68 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 crossfunctional global initiatives in a matrixed organization.
• Experience supporting audits and/or regulatory inspections.
• Strong analytical problemsolving and riskbased decisionmaking 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 peopleleadership 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 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

The anticipated base pay range for this position is :

$102000.00 - $177100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

Manager