Regulatory Affairs Manager — Devices and Software (m/f/d)
To support our Applications team in Hamburg, we are looking for a highly motivated and committed Regulatory Affairs Manager – Devices and Software (m/f/d)
- Execution of international registrations of instruments (real-time PCR cyclers, pipetting robots) and software for in vitro diagnostic use
- Support of the R&D department with respect to applicable legal and normative requirements
- Communication with regulatory authorities as well as with our international subsidiaries and distributors regarding product registrations
- Compilation and maintenance of the technical product documentation
- Supervision and evaluation of product changes from a regulatory perspective
- Successful completion of a master’s degree in natural science or engineering or comparable qualification
- Several years of experience in regulatory affairs in the field of medical devices with a focus on instruments and software (experience in the IVD field of advantage)
- Ideally knowledge and experience regarding the registration of instruments and software as medical devices in Canada and the U.S.
- Excellent communication skills in English and German (written and spoken)
- Independent and solution-oriented way of working
- Strong communication and coordination skills
Benefit from the diverse opportunities of an expanding international company. Work independently and in a team in a highly motivated, open and friendly environment. Family-friendly working hours as well as a pleasant and familiar working atmosphere are waiting for you.
Are you interested?
Then we look forward to your detailed application stating your availability and your salary expectations. Your contact person is Ms. Dina Jensen.