Support the creation of IVDR-compliant clinical evidence documentation, including study plans and reports for regulatory submissions (PEP / PER, CPR, SVR, SOTA). * Contribute to coordination and implementation of clinical studies that support regulatory submissions, including pre-market approvals (PMA), 510(k) notification, and CE marking. * Ensure compliance with legal and regulatory requirements across different jurisdictions, including adherence to good clinical practice (GCP), ISO standards, and relevant in vitro diagnostic device regulations (IVDD / IVDR). ORGENTEC Diagnostika GmbH * Mainz * Feste Anstellung * Vollzeit - ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headqu
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