Global UDI Program Lead - Quality & Compliance

Johnson & Johnson MedTech; Ringaskiddy; On-site; EUR 102,000 - 175,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Global UDI to lead global compliance across orthopedic products. The role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity, system readiness, and regulatory compliance across markets.

This leadership position drives scalable, future‑ready UDI processes and systems, supporting patient safety and product traceability on a global scale.

Qualifications

• 6–8 years of QA, Regulatory Compliance, or Technology Quality within a regulated industry (medical devices strongly preferred).
• Demonstrated experience with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).
• Strong knowledge of quality systems, data governance, and computerized system validation.
• Proven ability to lead cross‑functional, global initiatives in a matrixed organization.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem‑solving, and risk‑based decision‑making skills.
• Excellent written and verbal communication skills.

Responsibilities

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

Advanced Analytics

Change Management

Data Analysis

Data Privacy Standards

Data Quality

Data Reporting

Data Visualization

Leadership

Strategic 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 is seeking a Manager, Global UDI to lead global compliance across orthopedic products. The role partners with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity, system readiness, and regulatory compliance across markets.

This leadership position drives scalable, future‑ready UDI processes and systems, supporting patient safety and product traceability on a global scale.