Regulatory Affairs Manager – Instruments & Software (m/f/d)
To strengthen our Regulatory Affairs team in Hamburg, we are looking for a highly motivated and dedicated Regulatory Affairs Manager – Instruments & Software (m/f/d)
- Development and implementation of strategies for international approval of in vitro diagnostic (IVD) devices and software
- Monitoring of the development of IVD devices and IVD software with regard to applicable legal and normative requirements
- Preparation and maintenance of technical documentation
- Communication with regulatory authorities as well as subsidiaries and international sales partners to determine regulatory requirements
- Support of subsidiaries and international distribution partners in local product approval/registration
- Monitoring and evaluation of product changes from a regulatory perspective
- Completed technical/scientific studies or a comparable qualification
- At least 5 years of experience in the field of international approvals of medical devices with a focus on devices and software (experience in the IVD field an advantage)
- Several years of practical experience regarding the approval of medical devices (devices and software) according to the 510(k) process in the USA (ideally in the field of in vitro diagnostics; experience with approvals according to the PMA process is an advantage)
- Very good knowledge of written and spoken English
- Independent and solution-oriented way of working
- Strong communication and coordination skills
Benefit from a wide range of opportunities available within an expanding international company. You will work both independently and as part of a team in a highly motivated, open, and friendly environment. Family-friendly working hours along with a pleasant and familial working atmosphere await you.
Are you interested?
Then we are looking forward to receiving your detailed application including your availability and salary expectations. Please send us your complete application documents (ideally in PDF format) using the “Apply here” button. Your contact person is Ms. Dina Jensen.