Senior Technical Certifier in the field of certification of in-vitro diagnostic medical devices (f/m/d)

Careworkers & Health

29/06/2020

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).

Deine Aufgaben:

- 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

Dein Profil:

- 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...

  • Employment
    Full-time

pin iconMunich

Hiring company

TÜV SÜD AG

With your consent, we would like to use cookies and similar technologies to enhance your experience with our service. You can learn more about this in our Privacy Policy page