Global UDI Compliance & Quality Leader

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation 120 hours per calendar year

Sick time 40 hours per calendar year

Holiday pay

Job summary

Johnson & Johnson is recruiting a Manager, Global UDI to lead global UDI program compliance across markets. This leadership role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity and regulatory readiness.

The role focuses on scalable UDI processes, systems, and governance to support patient safety and product traceability across the orthopaedics portfolio and beyond.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems or related field required.
• Master’s degree in scientific, technical, or business discipline preferred.

Responsibilities

• Lead global UDI program ensuring compliance with FDA, EU MDR and other regulations.
• Own UDI data management, quality processes, change control, and issue remediation.
• Partner with IT and digital teams for system design, validation, data integrity and ongoing compliance.
• Support regulatory inspections and health authority interactions related to UDI compliance.
• Drive continuous improvement to governance, efficiency, and sustainability of UDI processes.
• Provide coaching and leadership to team members to strengthen UDI capabilities across the organization.

Skills

UDI regulations

Quality systems

Data governance

Cross-functional leadership

Regulatory inspections

Analytical thinking

Education

Bachelor’s degree in Engineering, Life Sciences, Information Systems

Master’s degree (preferred)

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson is recruiting a Manager, Global UDI to lead global UDI program compliance across markets. This leadership role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity and regulatory readiness.

The role focuses on scalable UDI processes, systems, and governance to support patient safety and product traceability across the orthopaedics portfolio and beyond.