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About the Role
Functieomschrijving
- Defining applicable standards and regulations for new products, such as IEC 60601 series, IEC 62304, IEC 62366-1, and EU MDR.
- Outlining how these standards and regulations will be integrated into the Standards and Compliance plan to demonstrate compliance.
- Creating project deliverables related to Norm Compliance.
- Ensuring all specified legal requirements are implemented and verified by reviewing relevant project deliverables.
- Assisting designers and testers with the interpretation and application of standards and regulations related to the technical design of IGT products.
- Organizing and completing all documentation required to obtain product certification from independent certifying agencies.
- Providing technical support to the Regulatory Affairs department in preparation for submissions to regulatory bodies.
Functie-eisen
- A bachelor’s degree or higher in a techn...
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