Requirements:

QA & RA Engineer with relevant experience with R&D activities and specifically TAVI (Transcatheter Aortic Valve Implantation) /Cardiology field.

Well experienced with ISO 13485, specifically Design controls and V&V activities.

Experienced with ISO 5840-3 and ISO 10555-X and other relevant standards.

Experienced with review/guidance for V&V Protocols, execution and reports for regulatory submission

Defining samples size/ support with protocol and execution discrepancies - while working according to companies’ procedures.

Generation of formal Quality documentation associated with the V&V execution
(not test execution)

Experiments raw data review.