Global UDI Manager

Johnson & Johnson

Manager, Global UDI at DePuy Synthes ensuring compliance with UDI regulations. Leading a global program to support patient safety, product traceability, and regulatory readiness.

Posted 6/8/2026full-timeRaynham • Massachusetts, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $117,000 - $234,000 per yearWebsite

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
Own UDI-related quality processes, procedures, and controls, ensuring alignment with standards.
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, and issue remediation.
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 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.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.
6–8 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 lead cross-functional, global initiatives in a matrixed organization.
Experience supporting audits and regulatory inspections.
Strong analytical, problem-solving, and risk-based decision-making skills.
Excellent written and verbal communication skills.
Experience working with enterprise systems supporting UDI and product data (e.g., ERP, PLM, labeling systems) preferred.
Prior people-leadership or matrix leadership experience preferred.
Familiarity with global supply chain and labeling processes preferable.
Change management or continuous improvement experience in regulated environments preferable.
English (additional languages a plus)

Benefits

Comp & perks

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Hard Skills & Tools

UDI regulationsquality systemsdata governancecomputerized system validationregulatory compliancequality assurancechange managementcontinuous improvementrisk-based decision-makinganalytical skills

Soft Skills

leadershipcross-functional collaborationproblem-solvingcommunication skillscoachingstakeholder engagementmatrix leadershiporganizational skillsteam managementadaptability