Manager, Global UDI

Job Overview

The Manager Global UDI is a key leadershiproleresponsiblefor ensuring global compliance governance and execution of Unique Device Identification (UDI) requirements across DePuy Synthes orthopedic portfolio. This role partners closely with Regulatory Affairs IT Supply Chain R&D and Commercial teams to ensure UDI data integrity system 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 scalablefuturereadyUDI processes and systems.

Key Responsibilities

• Lead and govern the global UDI program ensuring compliance with FDA EU MDR and other applicable international UDI regulations.

• OwnUDIrelatedquality processes procedures and controls ensuring alignment withstandards.

• Partner with IT and digital teams to ensure UDI system design validation data integrity and ongoing system compliance.

• Provide quality oversight for UDI data management including master data accuracy change control andissueremediation.

• Leadcrossfunctionalcollaboration with Regulatory Affairs Supply Chain Manufacturing R&D and Commercial teams to ensureendtoendUDI execution.

• Support andparticipatein 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 processes.

• Drive continuous improvement initiatives to enhance UDI governance efficiency and compliance sustainability.

• Provide coaching and leadership to team members and stakeholders to strengthen UDI and quality capabilities across the organization.

Qualifications

Education

• Required:Bachelors degree in Engineering Life Sciences Information Systems ora relatedfield.

• Preferred: Masters degree in a scientific technical or business discipline.

Experience and Skills

Required:

• 68 years of relevant 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).

• Strong knowledge of quality systems data governance and computerized system validation.

• Proven ability to leadcrossfunctional global initiatives in a matrixed organization.

• Experience supporting audits and regulatory inspections.

• Strong analyticalproblemsolving andriskbaseddecisionmakingskills.

• Excellent written and verbal communication skills.

Preferred:

• Experience working with enterprise systems supporting UDI and product data (e.g. ERP PLM labeling systems).

• Priorpeopleleadershipor matrix leadership experience.

• Experience within orthopedics or complex medical device portfolios.

• Familiarity with global supply chain and labeling processes.

• Change management or continuous improvement experience in regulated environments.

Other

• Language: English (additionallanguages a plus).

• Travel: Up to 1020% domestic and international.

• Certifications: ASQ RAC or equivalent quality/regulatory certifications preferred.

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Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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.

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