Global UDI Leader - Compliance & Data Integrity

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

Benefits offered by this job

Vacation 120 hours

Sick time

Parental Leave

Volunteer Leave

Job summary

Johnson & Johnson is seeking a Manager, Global UDI to lead global UDI governance, data integrity, and regulatory readiness for the orthopedic portfolio across Raynham, MA and Ringaskiddy, Ireland. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to shape scalable UDI processes and systems.

The role emphasizes leadership in a matrix organization, regulatory inspection support, and continuous improvement to ensure patient safety and product traceability across

Qualifications

• 6–8 years in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry (medical devices strongly preferred).
• Experience with UDI regulations and global regulatory frameworks (FDA, EU MDR).
• Strong knowledge of quality systems, data governance, and computerized system validation.

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 Quality

Leadership

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 UDI governance, data integrity, and regulatory readiness for the orthopedic portfolio across Raynham, MA and Ringaskiddy, Ireland. You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to shape scalable UDI processes and systems.

The role emphasizes leadership in a matrix organization, regulatory inspection support, and continuous improvement to ensure patient safety and product traceability across