Global UDI Program & Compliance Lead

Johnson Johnson; Jacksonville (FL); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Manager, Global UDI Process and Governance, to lead a global program ensuring regulatory compliance across markets. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to design scalable UDI data capabilities and governance aligned with quality standards.

The role focuses on driving process ownership, data integrity, and readiness for inspections, while shaping future UDI capabilities for patient safety and product traceability

Qualifications

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

Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
• Drive governance for functional data owners connected to UDI Health Authority records.
• Own UDI‑related processes, procedures, and controls, ensuring alignment with quality/regulatory standards.
• Partner with technology and digital teams to ensure capabilities to execute UDI related processes are established and maintained to meet UDI requirements.
• Lead cross‑functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure governance is met with data and 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 management system processes.
• Drive continuous improvement initiatives to enhance UDI data utilization, efficiency, and compliance sustainability including ownership of required periodic reviews to demonstrate effective processes and execution to compliance requirements.
• Provide coaching and leadership to team members and stakeholders to strengthen UDI knowledge and capabilities across the organization.

Skills

Agile Decision Making

Cross-Functional Collaboration

Leadership

Project Management

Quality Assurance (QA)

Data Governance

Regulatory Compliance

Analytical Thinking

Education

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

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

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson MedTech seeks a Manager, Global UDI Process and Governance, to lead a global program ensuring regulatory compliance across markets. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to design scalable UDI data capabilities and governance aligned with quality standards.

The role focuses on driving process ownership, data integrity, and readiness for inspections, while shaping future UDI capabilities for patient safety and product traceability