Ivdr Product Assessor - Tt615

Job DescriptionAs an IVDR Product Assessor, you will use your skills as an expert in clinical diagnostic technologies to ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new European In Vitro Diagnostics Regulation.Your role will be to assess in-vitro diagnostic medical devices for strict compliance with the relevant European laws (EU IVDR; Regulation 2017/746). Your key task will be carrying out reviews of the manufacturers' technical documentation as part of the CE marking process.This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail.Key Responsibilities:Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B and Class C devices within a defined timeframe, by verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.Provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials.Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification.Expand and keep up-to-date your knowledge of relevant technologies, regulations, international standards and best practice guidance documents.
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