Regulatory Affairs Specialist with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation).
The RAS is responsible for preparation & revision of IVD technical files when needed, updating labelling to comply with IVDR requirements, and tracking RA Regional notifications.
Responsibilities:
Support the IVDR project by revising the assigned technical files.
Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity.
Each technical file must include the latest version of the required technical reports, validations, test reports and other docu...