Global UDI Program Manager

Brighter Signals; Loughbeg; On-site; EUR 104,000 - 180,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time –40 hours per calendar year

Holiday pay

Job summary

Johnson & Johnson’s DePuy Synthes division seeks a Manager, Global UDI to lead global UDI governance across orthopedic portfolios, ensuring regulatory compliance, data integrity, and system readiness in multiple markets.

You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to drive scalable processes, participate in inspections, and coach teams toward strong quality capabilities.

Qualifications

• Required: 6–8 years in Quality Assurance, Regulatory Compliance, or Technology Quality in a regulated industry (medical devices preferred).
• Demonstrated experience with UDI regulations and global regulatory frameworks (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

Critical Thinking

Data Analysis

Data Privacy Standards

Data Quality

Data Reporting

Data Savvy

Data Science

Data Visualization

Developing Others

Digital Fluency

Inclusive Leadership

Leadership

Process Optimization

Relationship Building

Statistical Computing

Strategic Thinking

Education

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

Master’s degree in scientific, technical, or business discipline (preferred)

Tools

ERP

PLM

Labeling systems

Job description

Johnson & Johnson’s DePuy Synthes division seeks a Manager, Global UDI to lead global UDI governance across orthopedic portfolios, ensuring regulatory compliance, data integrity, and system readiness in multiple markets.

You will partner with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to drive scalable processes, participate in inspections, and coach teams toward strong quality capabilities.