Program Manager, Product Environmental Compliance & Regulatory Affairs
Stryker · Duisburg, North Rhine-Westphalia, Germany · €79K–€147K/yr
Medical Equipment Manufacturing · 10,001+ employees
About the role
The Program Manager is responsible for planning and executing global regulatory affairs and environmental compliance programs within the logistics and distribution network. They act as the primary liaison between operations and corporate stakeholders to ensure consistent implementation of regulatory requirements and readiness for audits.
What they look for
Requirements
Candidates must hold at least a Bachelor's degree in Science or Engineering and possess over 8 years of experience in regulatory affairs or compliance within a regulated industry. Proficiency in EU environmental, packaging, and battery regulations, along with experience in ISO 13485 or FDA-regulated quality systems, is required.
Benefits
Full description
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.
Netherlands Pay Ranges:
- Netherlands: €79.200 - €147.000 EUR Annual
Germany Pay Ranges:
- Duisburg: €80.400 - €133.900 EUR Annual
United Kingdom Pay Ranges:
- United Kingdom: £59,900 - £99,800 GBP Annual
At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
Travel Percentage: 20%