Program Manager, Product Environmental Compliance & Regulatory Affairs
Core
Planning, coordinating, and executing global Regulatory Affairs and Product Environmental Compliance programs for Global Logistics activities and distribution networks.
Role type
Senior Program Manager, Regulatory Affairs & Product Environmental Compliance
Builds
Global compliance programs for logistics operations, distribution centers, and product distribution networks
Domain
Medical devices / Global Logistics / Environmental Compliance
Deliverable
client delivery
Required skills
Global program management, regulatory strategy alignment, risk management, executive reporting, stakeholder coordination, audit support, budget management, training execution, continuous improvement
Preferred skills
Medical device regulatory experience, supply chain/logistics background, sustainability process knowledge
Technologies
ISO 13485, MDR, FDA quality systems, EU PPWR, EU Battery Regulation
Responsibilities
Leading global RA & PEC programs, establishing program governance, coordinating PEC implementation for packaging/batteries, acting as correspondent for health authorities, evaluating regulatory impacts, reporting budget actuals, training staff on registration obligations, supporting audits, coordinating Economic Operator obligations, partnering with cross-functional teams, monitoring program performance via KPIs
Seniority
Senior, hands-on IC