Johnson & Johnson

Manager, Global UDI

Johnson & Johnson
Posted 10/20/2026full-timeUnited StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite
Apply

Core Competencies

Role fit
Core 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 continuous improvement within regulated environments.

Highest-signal resume keywords
UDI RegulationsQuality AssuranceRegulatory ComplianceData GovernanceCross-Functional Leadership

Tech Stack

Tools & technologies
ERP

About the role

Key responsibilities & impact
  • Lead and govern the global UDI program across DePuy Synthes’ orthopedic portfolio
  • Ensure 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 compliance
  • Provide quality oversight for UDI data management, master data accuracy, change control, and issue remediation
  • Lead collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams
  • Support regulatory inspections, internal audits, and health authority interactions related to UDI compliance
  • Monitor global regulatory trends and translate evolving requirements into scalable business and quality processes
  • Drive continuous improvement to enhance UDI governance, efficiency, and compliance sustainability
  • Coach and provide 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 proficiency
  • Up to 10–20% domestic and international travel
  • 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 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 preferred

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
  • 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
  • Company benefits information available at https://www.careers.jnj.com/employee-benefits

ATS Keywords

✓ Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Quality SystemsComputerized System ValidationChange ControlIssue RemediationData IntegrityRegulatory InspectionsAnalytical SkillsProblem-Solving SkillsRisk-Based Decision-MakingMaster Data Accuracy
Soft Skills
Excellent Communication SkillsLeadershipCollaborationCoachingAnalytical Thinking
Tools & Technologies
ERP SystemsPLM SystemsLabeling SystemsDigital SystemsQuality Management Systems
Certifications & Qualifications
ASQ CertificationRAC Certification
Industry Keywords
OrthopedicsMedical DevicesRegulated IndustryGlobal Regulatory FrameworksSupply Chain Processes