Global UDI PMO Lead — Regulatory Excellence & Impact

Johnson & Johnson Co.

Cork

Sur place

EUR 109 000 - 191 000

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Avantages offerts par ce poste

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay, including Floating Horses

Résumé du poste

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead strategic planning, governance, and execution of the Unique Device Identification program. The role ensures global regulatory compliance, data integrity, and scalable UDI processes across systems and partners, with high visibility and cross‑functional leadership across the DePuy Synthes portfolio.

The role offers the chance to influence patient safety and regulatory outcomes while managing a global, multi‑country program and

Qualifications

  • Bachelor’s degree in a related field is required; advanced degree preferred.
  • 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry.
  • Demonstrated leadership of complex, cross‑functional programs with global scope.
  • Strong knowledge of UDI regulations and quality system requirements.
  • Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).
  • Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Responsabilités

  • 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.

Connaissances

Global leadership
UDI regulations
Quality systems
PMO / Project management
Risk management
Communication
Team leadership
Regulatory inspections
Cross‑functional collaboration

Formation

Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field
Master’s degree (MS, MBA) preferred

Outils

ERP systems
Labeling systems
Regulatory systems
Master data systems

Description du poste

Johnson & Johnson is seeking a Sr Manager Global UDI PMO to lead strategic planning, governance, and execution of the Unique Device Identification program. The role ensures global regulatory compliance, data integrity, and scalable UDI processes across systems and partners, with high visibility and cross‑functional leadership across the DePuy Synthes portfolio.

The role offers the chance to influence patient safety and regulatory outcomes while managing a global, multi‑country program and

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