Job Description
Technical Documentation Reviewer (Medical Devices)Role Overview: Join my clients team to conduct technical documentation reviews for Class I/IIa/IIb and/or Class III medical devices, ensuring compliance with European Medical Device Directive and Medical Device Regulation. Support CE marking activities and assist various teams with technical queries.Key Responsibilities:Review technical documentation against EU regulations within set timeframes.Support sales, CWS approvers, and scheduling teams with technical issues.Ensure reviews meet all regulatory requirements.Train and qualify colleagues, and create training materials.Communicate effectively with team members and clients.Minimize risks associated with medical device certification.#Requirements:In-depth knowledge of EU Medical Device Directive (93/42/EEC) and Regulation (EU) 2017/745.Familiarity with EU harmonized medical devices standards (e.g., EN 14971:2019, EN 14155:2020).Understanding of European Medical Devices Nomenclature (EMDN).Strong written and verbal communication skills in English.Ability to meet KPIs and manage workload efficiently.