As one of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day
Please join us as
: Senior Regulatory Affairs Expert (m/f)
The regulatory affairs department is responsible for worldwide registration of the newly developed products and the existing portfolio. With newly developed class III innovate products, including combination products, the regulatory affairs department offers a great opportunity to work on challenging regulatory submissions.
Your ResponsibilitiesYour Profile
- Being responsible for regulatory aspects during the development of new VI products (regulatory strategy & inputs)
- Regulatory of VI devices in the CE, US, Japan and other assigned markets
- Maintaining regulatory documentation up to date for worldwide regulatory purposes
- Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient work flow within the department and project team
- Coordinating and submitting deficiency responses to relevant certification bodies and competent authorities
- University degree in natural science, pharmacy, pharmacology, medicine or engineering
- At least 5 years experience with worldwide registrations of medical devices and/or combination products in relevant countries, particularly in the CE region and in the USA
- Literate in MS Office applications; SAP knowledge is an advantage
- Fluency in English and good German (at least B1-Level); any other language is an asset
- Independent, reliable and communicative personality, who is able to deliver high quality work even under pressure and to handle several projects simultaneously
Are you interested? Please apply online! We are looking forward to welcoming you.
Working hours: Vollzeit
Type of contract: Unbefristet
Job ID: 2717
Contact: Bianca Wisner
Tel.: +41 44 864 5107
We do not accept applications from Headhunters.