Global UDI Program Lead

Antler; Raritan (NJ); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time – 40 hours/year

Parental Leave – 480 hours

Job summary

Johnson & Johnson / DePuy Synthes is seeking a Manager, Global UDI, to lead a global UDI program ensuring regulatory compliance, data integrity, and system readiness across orthopedic portfolios. The role collaborates with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to drive scalable UDI processes.

The position emphasizes governance, quality controls, and readiness for regulatory inspections, with travel up to 10–20% and global impact on patient safety and product

Qualifications

• Bachelor's degree in a relevant field is required
• Master's degree preferred in a scientific, technical, or business discipline
• 6–8 years of experience in QA, regulatory compliance, or technology quality in a regulated industry

Responsibilities

• Lead the global UDI program ensuring compliance with FDA, EU MDR and other international regulations
• Own UDI-related quality processes, procedures, and controls
• Partner with IT and digital teams for system design, validation, data integrity, and ongoing compliance
• Provide quality oversight for UDI data management including master data accuracy and change control
• Lead cross-functional collaboration across Regulatory Affairs, Supply Chain, Manufacturing, R&D and Commercial teams
• Support regulatory inspections, internal audits, and health authority interactions
• Monitor regulatory trends and translate requirements into scalable processes
• Drive continuous improvement to governance and compliance
• Coach and develop team members to strengthen UDI and quality capabilities

Skills

Analytical thinking

Regulatory compliance

Quality systems

UDI knowledge

Cross-functional leadership

Education

Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field

Master's degree (preferred)

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson / DePuy Synthes is seeking a Manager, Global UDI, to lead a global UDI program ensuring regulatory compliance, data integrity, and system readiness across orthopedic portfolios. The role collaborates with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to drive scalable UDI processes.

The position emphasizes governance, quality controls, and readiness for regulatory inspections, with travel up to 10–20% and global impact on patient safety and product