Scientific Staff Member, Medical Devices Department | Wissenschaftliche Mitarbeiter:innen (m/w/d) in der Abteilung Medizinprodukte (EG 14 TV-L / A 14 L)
Bezirksregierung Köln
Job Summary
The Central Authority of the German Federal States for Health Protection regarding Medicinal Products and Medical Devices (ZLG) is seeking several Scientific Staff Members for its Medical Devices Department in Bonn. This role is crucial for ensuring the marketability of medical devices across Europe. Day-to-day tasks include conducting designation procedures for conformity assessment bodies (Notified Bodies) and regularly assessing and monitoring these bodies, including observing audits at manufacturers. The position also involves reviewing technical documentation and participating in designation procedures with other European authorities. Key requirements include a university degree in a medical, natural, or engineering science, with a preference for a doctorate, along with significant experience in medical devices, particularly concerning software, AI, and cybersecurity. The ideal candidate will possess strong communication skills in German and English, be willing to travel frequently, and demonstrate a structured, independent, and team-oriented work ethic.
Required Skills
Education
University degree in a medical, natural, or engineering science, preferably with a doctorate.
Experience
- Several years of experience in medical devices/in-vitro diagnostics, preferably from a manufacturer or testing laboratory
- Experience in Artificial Intelligence, Software as a Medical Device, and Cybersecurity in Medical Devices
- Knowledge in Quality Management, preferably according to DIN EN ISO 13485
- Experience with administrative procedures
- Inspection, assessment, or audit experience (advantageous)
Languages
Additional
- Willingness to travel frequently, including multi-day business trips domestically and internationally. Applicants with foreign educational qualifications must provide proof of equivalence with a German degree. For non-EU citizens, a valid work permit is required.
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