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Posted: 10/20/2026Manager, Global UDI
Johnson & JohnsonCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in UDI program governance, ensuring compliance with FDA and EU MDR regulations while leading cross-functional initiatives. Proficient in quality systems, data governance, and regulatory inspections within a matrixed organization.
Highest-signal resume keywords
UDI Regulations ComplianceQuality Systems ManagementCross-Functional LeadershipRegulatory Inspection SupportData Governance
Tech Stack
Tools & technologiesAbout 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
- Partner with IT and digital teams on 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
- 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 for UDI governance, efficiency, and compliance sustainability
- Provide coaching and leadership to team members and stakeholders
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
- Demonstrated experience with UDI regulations and global regulatory frameworks, including FDA and 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
- English language
- Up to 10–20% domestic and international travel
- 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 orthopedics or complex medical device portfolios
- Preferred: familiarity with global supply chain and labeling processes
- Preferred: change management or continuous improvement experience in regulated environments
- Preferred: ASQ, RAC, or equivalent quality/regulatory certifications
Benefits
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 Colorado employees; 56 hours for Washington employees
- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceRegulatory ComplianceComputerized System ValidationChange ControlRisk-Based Decision Making
Soft Skills
Analytical SkillsProblem-Solving SkillsWritten CommunicationVerbal CommunicationCoaching
Tools & Technologies
ERP SystemsPLM SystemsLabeling Systems
Certifications & Qualifications
ASQ CertificationRAC Certification
Industry Keywords
Global Regulatory FrameworksMedical Device ComplianceContinuous ImprovementSupply Chain ProcessesOrthopedics