Regulatory Affairs Submissions Contractor
EPM Scientific are seeking a freelancer based in the Netherlands to support a large medical device manufacturer on their MDR compliance activities and general regulatory activities to ensure compliance for their product portfolio.
Responsibilities
- Identification of regulatory requirements for new & existing products.
- Information gathering to support regulatory submissions.
- Regulatory strategy advise to support regulatory submissions.
- Supporting the wider team on regulatory requirements as required.
- External interactions across stakeholders, manufacturers, suppliers, and health authorities to ensure compliant products.
Contract
- 6 months with possible extensions
- 0.8 - 1 FTE
- Remote based in the Netherlands
Experience requirements
- 5+ years experience in regulatory affairs for medical devices
- Understanding of MDR regulations
- Experience with global medical devices across regions such as APAC, LATAM, and North America
- Dutch and English Speaking
Please apply now for immediate consideration.
