Global UDI Compliance & Data Strategy Manager

6209-Medical Devices & Diagnostics Global Services, LLC Legal Entity; Raritan Township (ND); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Manager, Global UDI Regulations and Data Strategy to lead the global UDI program across markets, ensuring regulatory compliance and scalable data strategies. The role partners with Regulatory Affairs, IT, Supply Chain, R&D and Commercial teams to execute UDI requirements and improve data capabilities.

The position emphasizes collaboration, regulatory inspections support, and continuous improvement in a regulated medical devices environment, with travel up to 15%.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems or related field.
• Master’s degree in a scientific/technical/business discipline preferred.
• 6–8 years in Quality Assurance, Regulatory Compliance or Technology Quality in regulated industry (medical devices preferred).
• Experience with UDI regulations and global regulatory frameworks (FDA, EU MDR).
• Strong understanding of quality systems, data governance and computerized system validation.
• Proven ability to lead cross-functional, global initiatives in a matrix organization.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, and risk-based decision-making skills.
• Excellent written and verbal communication skills.
• Experience with ERP/PLM and labeling systems is a plus.
• People leadership experience and familiarity with medical device portfolios.
• Knowledge of product lifecycle, global supply chain and labeling processes.

Responsibilities

• Lead and govern the global UDI program with FDA, EU MDR and other regulations.
• Drive strategy for data use within UDI Health Authority records.
• Own UDI processes, controls, and alignment with quality standards.
• Partner with technology and digital teams to meet UDI requirements.
• Lead cross-functional collaboration across Regulatory, Supply Chain, Manufacturing, R&D and Commercial teams.
• Support regulatory inspections and health authority interactions related to UDI compliance.
• Monitor regulatory trends and translate requirements into scalable processes.
• Drive continuous improvement to enhance UDI data utilization and compliance.

Skills

UDI regulations

Global regulatory frameworks

Data governance

Quality systems

Cross-functional leadership

Audits & inspections

Regulatory strategy

Analytical thinking

Project management

Regulatory negotiations

Education

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

Master’s degree preferred

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson MedTech seeks a Manager, Global UDI Regulations and Data Strategy to lead the global UDI program across markets, ensuring regulatory compliance and scalable data strategies. The role partners with Regulatory Affairs, IT, Supply Chain, R&D and Commercial teams to execute UDI requirements and improve data capabilities.

The position emphasizes collaboration, regulatory inspections support, and continuous improvement in a regulated medical devices environment, with travel up to 15%.