Senior Technical Certifier in the field of certification of in-vitro diagnostic medical devices (f/m/d)
Senior Technical Certifier in the field of certification of in-vitro diagnostic medical devices (f/m/d).
- Handling of certification processes and conformity evaluation processes according to IVDD and/or IVDR in the field of IVD medical products - Assuring the application of the QM system in the department - Representing the department in front of external actors within the framework of talks, lectures and meetings with clients - Clarifying technical questions raised by project leaders, auditors, experts in the field and clients on behalf of certification managers - Technical handling of appeals from clients - Supporting the certification body’s management in formulating replies to queries and requests by competent authorities - Supporting the certification body’s management in the organisation of audits by the authorities and assisting in surveys or evaluations in audits carried out by the authorities - Maintaining the authorisations through the review of technical documentations of IVD products as well as the execution of audits, including the technical reports associated with such audits - Carrying out technical evaluations and making the final decision regarding certifications and maintenance of certification - Supporting projects in the frameworks of the maintenance of the TÜV SÜD Product Service GmbH accreditation/designation - Conducting internal audits at TÜV SÜD Product Service GmbH’s international certification branches - Technical processing of client vigilance information and incidents - Supporting, training and monitoring of technical certifiers
- Master´s or engineering degree in a natural sciences discipline such as biochemistry, biotechnology, chemistry etc. - At least 4-5 years of experience in the field of medical devices and/or related services and/or at least 4-5 years of experience working at notified body - Preferably background working as a technological auditor or technical assessor in the field of in-vitro di...