Global UDI PMO Lead - Regulatory & Quality Impact

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Raynham (MA); Presencial; USD 122.000 - 213.000; Jornada completa

Descripción de la vacante

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

You will oversee governance, roadmaps, milestones, and performance metrics to ensure timely, compliant delivery, while driving collaboration with

Formación

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or related field is required.
• Master’s degree (MS, MBA) in a relevant discipline is preferred.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
• 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.

Responsabilidades

• 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.

Conocimientos

Leadership of complex programs

UDI regulations

Quality system knowledge

ERP and regulatory systems

Stakeholder influence

Educación

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

Master’s degree (MS, MBA) in a relevant discipline

Descripción del empleo

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

You will oversee governance, roadmaps, milestones, and performance metrics to ensure timely, compliant delivery, while driving collaboration with