Ivdr Product Assessor

hace 2 meses

Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completo

.We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.Our Innovation Factory promotes and develops digital innovation initiatives across SGS; we deliver solutions tothe business at scale and speed. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.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.QualificationsWe are seeking an experienced candidate with:At least 4 years of professional experience within the domain of healthcare products or in related activities. This may include roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical setting. Among these, a minimum of 2 years should involve direct engagement in the design, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research

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