Product Reviewer

Join the GMED team today and work on the frontier of Medical Device Innovation! Reports to: Unit Manager Division: Certification Position Classification: Exempt, Full-Time Fields: Medical Devices, In-Vitro Diagnostics - Healthcare Location(s): Rockville, MD or Remote (Home office) Job Description As part of your mission as an evaluator/product reviewer, you will be responsible for carrying out evaluations as part of the CE marking conformity assessment procedures in the field of medical devices. You will be responsible for reviewing the design dossiers / technical documentation independently or as a team of evaluators for a range of medical devices with the goal of verifying whether the devices meet the requirements of the relevant standards/regulation. The deliverable will be comprehensive review reports which either support or reject the manufacturer's application for CE marking based on the evidence provided. Ultimately your work will determine whether a device has been demonstrated to be safe and effective, meets its intended use, and can be recommended for CE certification to the notified body. Essential Functions Conduct CE type and CE design dossier/product review evaluatio…