Senior Manager, UDI PMO

Johnson & Johnson

. Lead the UDI Program Management Office, establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements .

Posted 9/21/2026full-timeUnited StatesSenior💰 $122,000 - $245,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in UDI Program Management, ensuring compliance with global regulatory requirements while leading cross-functional teams. Proficient in managing program risks, optimizing processes, and driving strategic initiatives within regulated industries.

Highest-signal resume keywords

UDI Regulations KnowledgeProgram Management LeadershipCross-Functional Team LeadershipEnterprise Systems ExperienceProcess Improvement Initiatives

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Program ManagementRisk ManagementChange ControlQuality System RequirementsRegulatory ComplianceProcess OptimizationData IntegrityLean Six SigmaERP SystemsMaster Data Management

Soft Skills

Stakeholder InfluenceTeam LeadershipStrategic OversightCollaborationCommunication

Tools & Technologies

ERP SystemsLabeling SystemsRegulatory Submission SystemsQuality Management Systems

Certifications & Qualifications

PMPPgMPLean Six Sigma

Industry Keywords

Medical Device ManufacturingEU MDRFDA UDIRegulatory AffairsQuality Assurance

Tech Stack

Tools & technologies

ERPPMP

About the role

Key responsibilities & impact

Lead the UDI Program Management Office, establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements
Provide strategic oversight for UDI-related technology initiatives across ERP, labeling, master data, and regulatory submission systems
Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end UDI compliance and execution
Ensure inspection readiness through documentation, risk management, change control, and audit support processes
Lead and develop a team of PMO and UDI professionals
Monitor global regulatory changes related to UDI and assess business impact
Manage program risks, dependencies, and resource planning for compliant delivery of UDI initiatives
Drive process optimization and standardization using PMO best practices and quality system principles

Requirements

What you’ll need

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field
Typically 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry
Demonstrated leadership of complex, cross-functional programs with global scope
Strong knowledge of UDI regulations and quality system requirements
Experience working with enterprise systems, including ERP, labeling, master data, and regulatory systems
Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment
English required
Limited domestic and occasional international travel
Preferred: Master’s degree (MS, MBA) in a relevant discipline
Preferred experience supporting regulatory inspections and health authority audits related to UDI or data integrity
Preferred PMO leadership experience within Technology Quality or QA organizations
Preferred familiarity with EU MDR, FDA UDI, and global device registration frameworks
Preferred experience driving process improvement initiatives using Lean or Six Sigma
Preferred background in medical device manufacturing or orthopedic products
Preferred certifications: PMP, PgMP, Lean Six Sigma, or equivalent

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado residents – 48 hours per calendar year; Washington residents – 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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year