Manager, Global UDI Process – Governance

. Lead and govern the global UDI program .

Posted 9/25/2026full-timeUnited StatesMid-LevelSenior💰 $102,000 - $177,100 per yearWebsite

Tools & technologies

ERP

Key responsibilities & impact

Lead and govern the global UDI program
Ensure 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 in alignment with quality and regulatory standards
Partner with technology and digital teams to establish and maintain capabilities for UDI-related processes
Lead cross-functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams
Support and participate in regulatory inspections, internal audits, and health authority interactions related to UDI compliance
Monitor global regulatory trends and translate evolving UDI requirements into scalable business and quality management system processes
Drive continuous improvement to enhance UDI data utilization, efficiency, and compliance sustainability
Own required periodic reviews demonstrating effective processes and execution
Provide coaching and leadership to team members and stakeholders

What you’ll need

Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field
6–8 years of experience in Quality Assurance, Regulatory Compliance, or process engineering within a regulated industry
Medical device experience strongly preferred
Experience with UDI regulations and global regulatory frameworks, including FDA and EU MDR
Understanding of quality systems, data governance, and computerized system validation
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
English; additional languages a plus
Ability to travel up to 15%, domestically and internationally
Preferred: Master’s degree in a scientific, technical, or business discipline
Preferred: Experience with enterprise systems supporting UDI and product data, such as ERP, PLM, and labeling systems
Preferred: Prior people-leadership or matrix leadership experience
Preferred: Experience within complex medical device portfolios
Preferred: Familiarity with new product introduction, global supply chain, and labeling processes
Preferred: Change management or continuous improvement experience in regulated environments
Preferred: ASQ, RAC, or equivalent quality/regulatory certifications

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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 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