Job Description
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.