Global UDI PMO Lead | Strategy & Compliance

Brighter Signals; Cork; On-site; EUR 109,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Manager Global Unique Device Identifier (UDI) PMO to lead governance, planning, and execution of the UDI program across global operations.

The role drives regulatory compliance, data integrity, and scalable processes within the DePuy Synthes portfolio. You will partner with Quality, Regulatory, IT, Supply Chain, and Commercial teams to ensure inspection readiness, risk management, and timely updates to regulatory requirements.

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field.
• 8–10 years in Quality, Regulatory, Technology, or Program Management in a regulated industry (medical device preferred).
• Experience leading complex, cross-functional programs with global scope.
• Strong knowledge of UDI regulations and quality system requirements.
• Experience working with ERP, labeling, master data, and regulatory systems.
• Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Responsibilities

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
• Provide strategic oversight for UDI-related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end UDI compliance and execution.
• Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.
• Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
• Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
• Manage program risks, dependencies, and resource planning to ensure on-time, compliant delivery of UDI initiatives.
• Drive process optimization and standardization using PMO best practices and quality system principles.

Skills

Leadership

Cross-functional

Regulatory knowledge

PMO management

Quality systems

Education

Bachelor’s degree in Engineering or related field

Master’s degree (MS, MBA) preferred

Tools

ERP systems

Regulatory systems

Labeling systems

Master data

Job description

Johnson & Johnson is seeking a Sr. Manager Global Unique Device Identifier (UDI) PMO to lead governance, planning, and execution of the UDI program across global operations.

The role drives regulatory compliance, data integrity, and scalable processes within the DePuy Synthes portfolio. You will partner with Quality, Regulatory, IT, Supply Chain, and Commercial teams to ensure inspection readiness, risk management, and timely updates to regulatory requirements.