Manager, Global UDI

Johnson & Johnson Innovative Medicine

1d • $117,000 - $234,000 • Hybrid

About The Position

The Manager, Global UDI is a key leadership role responsible for ensuring global compliance, governance, and execution of Unique Device Identification (UDI) requirements across DePuy Synthes’ orthopedic portfolio. This role partners closely with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance across global markets. This position offers the opportunity to lead a globally impactful compliance program that directly supports patient safety, product traceability, and regulatory readiness while shaping scalable, future‑ready UDI processes and systems.

Requirements

• 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 (medical devices strongly preferred).
• Demonstrated experience with UDI regulations and global regulatory frameworks (e.g., FDA, 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 (additional languages a plus).

Nice To Haves

• Master’s degree in a scientific, technical, or business discipline.
• Experience working with enterprise systems supporting UDI and product data (e.g., ERP, PLM, labeling systems).
• Prior people‑leadership or matrix leadership experience.
• Experience within orthopedics or complex medical device portfolios.
• Familiarity with global supply chain and labeling processes.
• Change management or continuous improvement experience in regulated environments.
• ASQ, RAC, or equivalent quality/regulatory certifications preferred.

Responsibilities

• 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, ensuring alignment with standards.
• Partner with IT and digital teams to ensure 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 to ensure end‑to‑end UDI execution.
• 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 to enhance UDI governance, efficiency, and compliance sustainability.
• Provide coaching and leadership to team members and stakeholders to strengthen UDI and quality capabilities across the organization.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager