Work Flexibility: Hybrid
Job Mission / Purpose:
The Program Manager, Product Environmental Compliance & Regulatory Affairs (PEC & RA) Global Logistics Operations (GLO) is responsible for planning, coordinating, and executing global Regulatory Affairs and Product Environmental Compliance programs applicable to Global Logistics activities and distribution networks.
This role ensures that GLO Operations—including EU and global distribution centers —are compliant with applicable regulatory requirements related to environmental product compliance, packaging, batteries, and Economic Operator obligations. The Program Manager acts as the primary interface between GLO, Corporate RA/PEC programs, and cross‑functional stakeholders to ensure timely, consistent, and compliant implementation of regulatory requirements.
Key Activities & Responsibilities
- Leading global RA & PEC programs applicable to Global Logistics, ensuring alignment with Corporate and Divisional regulatory strategies and timelines.
- Establishing and maintaining program governance, including scope definition, milestones, risk management, dependency tracking, and executive reporting.
- Coordinating implementation of Product Environmental Compliance (PEC) requirements impacting logistics and distribution activities, including packaging, batteries, and restricted substances.
- Act as the official correspondent or responsible person to relevant health authorities for GLO sites.
- Evaluating impact of changing global regulations, including PEC requirements, on the GLO network and communicating impact to leadership.
- Supporting compliance with applicable regulations such as Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR), Battery Regulation (EU) 2023/1542 (BWBR), and related implementing acts.
- Report on budget actuals and project costs to management for activities supporting regulatory requirements.
- Training staff on, executing and monitoring registration and listing obligations for GLO sites globally.
- Supporting health authority and notified body audits as required and responding to health authority queries.
- Collaborating with Regulatory Affairs function to identify, draft and communicate device shortages to relevant health authorities.
- Coordinating RA‑related Economic Operator obligations (Importer and Distributor) as they apply to GLO operations, in close collaboration with Corporate RA and Legal.
- Acting as the primary GLO liaison to Corporate PEC and RA programs to ensure consistent interpretation, deployment, and execution across regions.
- Partnering with Quality Assurance, Supply Chain, Packaging Engineering, Sustainability, Operations, and Business stakeholders to drive end‑to‑end regulatory readiness.
- Ensuring appropriate regulatory documentation, evidence, and records are maintained to support audits, inspections, and market access requirements.
- Monitoring program performance through defined KPIs and readiness indicators, identifying gaps and driving timely corrective actions.
- Supporting continuous improvement of regulatory and compliance processes within Global Logistics.
- Promoting awareness of regulatory and environmental compliance requirements throughout the GLO organization.
Education
- Hon. Bachelor’s degree in Science, Engineering or related subject or equivalency is mandatory.
- Masters degree in Science, Engineering or related subject is preferred.
- Regulatory Affairs Certification (RAC) in medical devices is preferred.
Experience
- 8+ years of experience in Regulatory Affairs, Product Environmental Compliance, or regulatory program management within a regulated industry (medical devices preferred).
- Demonstrated experience managing complex, cross‑functional, global programs.
- Working knowledge of EU environmental, packaging, and battery regulations and their impact on logistics and distribution activities.
- Experience working within ISO 13485 / MDR / FDA‑regulated quality systems.
- Experience supporting distribution, logistics, or supply chain activities is preferred.
Travel Percentage: 20%
