Senior Manager, UDI PMO

Johnson & Johnson

. Lead the UDI Program Management Office, establishing governance, roadmaps, milestones, and performance metrics aligned with 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 process optimization and risk management within regulated industries, particularly in medical devices.

Highest-signal resume keywords

UDI Regulations KnowledgeProgram Management LeadershipEnterprise Systems ExperienceRegulatory Inspection SupportLean Six Sigma Methodology

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Program ManagementQuality System RequirementsRisk ManagementProcess OptimizationChange ControlDocumentation ManagementPerformance Metrics DevelopmentCross-Functional Team LeadershipRegulatory Submission SystemsMaster Data Management

Soft Skills

Stakeholder InfluenceTeam DevelopmentAccountability FosteringContinuous Improvement MindsetCommunication Skills

Tools & Technologies

ERP SystemsLabeling SystemsRegulatory SystemsQuality Management SystemsData Integrity Tools

Certifications & Qualifications

PMPPgMPLean Six Sigma

Industry Keywords

Medical DeviceEU MDRFDA UDIGlobal Device RegistrationOrthopedic Products

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 with 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
Maintain documentation, risk management, change control, and audit support processes to ensure inspection readiness
Lead and develop PMO and UDI professionals, fostering accountability, continuous improvement, and quality culture
Monitor global UDI regulatory changes, assess business impact, and drive timely implementation of updates
Manage program risks, dependencies, and resource planning for on-time, compliant delivery
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; medical device experience preferred
Demonstrated leadership of complex, cross-functional programs with global scope
Strong knowledge of UDI regulations and quality system requirements
Experience 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 language proficiency required
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
PMP, PgMP, Lean Six Sigma, or equivalent certification preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year 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 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
Inclusive interview process and accommodation support
Limited domestic and occasional international travel