Job description:
Yacht is looking for a specialist in Regulatory Compliance with strong knowledge and experience with Medical Device standards and regulations, to work at the large company in the Netherlands.
In this role, you will be responsible for providing support in the following activities:
- Development of the Standards and Compliance plan
- Creation the project deliverables related to Norm Compliance responsibilities.
- Definition of standards and regulations for products under development, such as , IEC 62304, IEC 60601-1 series, IEC 62366, and EU MDR.
- The implementation and verification of all specified legal requirements
- Support testers with the interpretation and testing of standards and regulations concerning the technical design of image-guided therapy (IGT) products.
- Technical support to the Regulatory Affairs department with for the preparation of submissions