Manager, Global UDI

This role is based in Raynham, MA (USA) and Ringaskiddy, Ireland. Requisition numbers: 078355 (Raynham) and 081281 (Ringaskiddy); applications to either are considered a single submission.

About the role

The Manager, Global UDI leads the global Unique Device Identification (UDI) program for DePuy Synthes’ orthopedic portfolio, ensuring compliance with FDA, EU MDR, and other international UDI regulations. This position partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to maintain UDI data integrity, system readiness, and regulatory compliance across global markets. The role supports patient safety, product traceability, and regulatory readiness while shaping scalable, future‑ready UDI processes and systems. Johnson & Johnson has announced plans to separate its Orthopaedics business to establish a standalone DePuy Synthes company; the separation is anticipated to complete within 18–24 months, after which this position would transfer to DePuy Synthes employment terms.

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.

Qualifications

Education: Required: Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field. Preferred: Master’s degree in a scientific, technical, or business discipline.

Required Experience and Skills:

• 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.

Preferred 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.

Other: Language: English (additional languages a plus). Travel: Up to 10–20%, domestic and international. Certifications: ASQ, RAC, or equivalent quality/regulatory certifications preferred.

Skills

Required Skills: Advanced Analytics, Change Management, Critical Thinking, Data Analysis, Data Privacy Standards, Data Quality, Data Reporting, Data Savvy, Data Science, Data Visualization, Developing Others, Digital Fluency, Inclusive Leadership, Leadership, Process Optimization, Relationship Building, Statistical Computing, Strategic Thinking.

Preferred Skills: (Same as required; the posting lists these as preferred competencies.)

Pay

Anticipated base pay range: $117,000.00 – $201,250.00. This position is eligible for the Company’s long‑term incentive program and consolidated retirement plan (pension) and savings plan (401(k)).

Benefits

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (Colorado residents: 48 hours; Washington residents: 56 hours)
• 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 birth/adoption/foster care
• Bereavement Leave – 240 hours for immediate family member; 40 hours for extended family member per calendar year
• Caregiver Leave – 80 hours in a 52‑week rolling period
• Volunteer Leave – 32 hours per calendar year
• Mil