Senior Manager, UDI PMO

Johnson & Johnson

Sr. Manager, UDI PMO leading strategic planning and execution of UDI programs at Johnson & Johnson.

Posted 6/8/2026full-timeRaynham • Florida, Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $122,000 - $245,000 per yearWebsite

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

UDI regulationsquality system requirementsprogram managementprocess improvementLeanSix Sigmarisk managementchange controlaudit supportenterprise systems

Soft Skills

leadershipinfluence stakeholdersdrive executioncommunicationdecision-makingaccountabilitycontinuous improvementteam developmentcross-functional collaborationinspection readiness

Tools & Technologies

ERP systemslabeling systemsmaster data systemsregulatory submission systems

Industry Keywords

medical deviceregulatory complianceglobal regulatory requirementsEU MDRFDA UDIhealth authority auditsmedical device manufacturingorthopedic productsprogram risksmatrixed environment

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
Provide strategic oversight for UDI-related technology initiatives, ensuring integration 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 by maintaining robust documentation, risk management, change control, and audit support processes.
Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
Manage program risks, dependencies, and resource planning to ensure on-time, compliant delivery of UDI initiatives.
Drive process optimization and standardization using PMO best practices and quality system principles.

Requirements

What you’ll need

Required: 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 preferred).
Demonstrated leadership of complex, cross-functional programs with global scope.
Strong knowledge of UDI regulations and quality system requirements.
Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).
Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.
Preferred: Experience supporting regulatory inspections and health authority audits related to UDI or data integrity.
PMO leadership experience within Technology Quality or QA organizations.
Familiarity with EU MDR, FDA UDI, and global device registration frameworks.
Experience driving process improvement initiatives (Lean, Six Sigma).
Background in medical device manufacturing or orthopedic products.
Excellent communication, risk management, and decision-making skills.
Language: English (required).

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year