Global UDI Program Lead - Compliance & Data Governance

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

Job summary

DePuy Synthes is seeking a Manager, Global UDI to lead global UDI governance and regulatory compliance across the orthopedic portfolio. This role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity and system readiness for global markets.

The position emphasizes cross-functional leadership, quality oversight of UDI data, and engagement in regulatory inspections, while driving scalable, future-ready UDI processes and systems.

Qualifications

• Bachelor’s degree required in engineering, life sciences, information systems or related field.
• Master’s degree preferred in a scientific, technical or business discipline.

Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other 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.

Skills

Quality Assurance

Regulatory Compliance

Data Governance

Cross-Functional Leadership

Audits & Inspections

Education

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

Master’s degree in a scientific, technical, or business discipline

Tools

ERP

PLM

Labeling Systems

Job description

DePuy Synthes is seeking a Manager, Global UDI to lead global UDI governance and regulatory compliance across the orthopedic portfolio. This role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity and system readiness for global markets.

The position emphasizes cross-functional leadership, quality oversight of UDI data, and engagement in regulatory inspections, while driving scalable, future-ready UDI processes and systems.