Global UDI Compliance Manager

Johnson and Johnson; Raritan (NJ); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Hybrid work model

Retirement plan (401(k) + pension)

Competitive compensation

Job summary

Johnson & Johnson, a global healthcare leader, seeks a Manager, Global UDI to lead regulatory‑driven UDI governance across Raynham, MA and Ringaskiddy, Ireland. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity, system readiness, and compliance across markets.

This leadership role focuses on scaling UDI processes, ensuring patient safety, product traceability, and regulatory readiness with continuous improvement and coaching to

Qualifications

• Requires 6–8 years in QA, regulatory compliance, or tech quality in regulated industries.
• Familiar with UDI regulations and global regulatory frameworks (FDA, EU MDR).
• Strong knowledge of quality systems, data governance, and CV validation.

Responsibilities

• Lead and govern the global UDI program ensuring regulatory compliance.
• Own UDI quality processes, procedures, and controls.
• Partner with IT/digital teams for system design, validation, data integrity.
• Provide oversight for UDI data management and change control.
• Lead cross‑functional collaboration to ensure end‑to‑end UDI execution.
• Support regulatory inspections and health authority interactions.
• Monitor regulatory trends and translate to scalable processes.
• Drive continuous improvement for governance and efficiency.
• Coach and lead team members to strengthen UDI capabilities.

Skills

Advanced Analytics

Change Management

Data Analysis

Data Privacy Standards

Data Quality

Data Reporting

Data Visualization

Developing Others

Leadership

Strategic Thinking

Statistical Computing

Relationship Building

Digital Fluency

Inclusive Leadership

Process Optimization

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

Johnson & Johnson, a global healthcare leader, seeks a Manager, Global UDI to lead regulatory‑driven UDI governance across Raynham, MA and Ringaskiddy, Ireland. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure data integrity, system readiness, and compliance across markets.

This leadership role focuses on scaling UDI processes, ensuring patient safety, product traceability, and regulatory readiness with continuous improvement and coaching to