Why Join Us?
We are an agile, young start-up with flat hierarchy. We believe in the fact that the team is an enabler for growth of the company and hence the company can grow only if the team members are motivated. We support team by:
- Work-life balance
- 100% Remote work possibility
- Flexible timing
- Good salary package
If you are motivated, please see below our open positions.
By submitting the application, you agree that the data voluntarily transmitted in the course of the online application and/or the data contained in the documents you send to us will be stored by us in an applicant database and processed as part of the application process. The data you provide will be kept strictly confidential and will not be disclosed to third parties. You have the option to revoke this consent at any time and, upon request, to obtain information about the personal data you have stored in the applicant database.
Our open positions
Your responsibilities:
- International registration and approval of Medical Devices / IVD Products
- Compilation of dossiers for international markets, especially for the markets in the USA, EU & Asia
- Renewal of registrations including market surveillance and reporting to the authorities
- Setting up Regulatory processes for MD / IVD clients
- Coordinating with R&D / Quality / other relevant departments on the implementation of technical documentation and labeling.
Requirements:
- Degree in natural sciences (e.g. pharmacy, biology) or corresponding professional
- Atleast 1 year in regulatory or quality in medical device or IVD field
- Experience with MDR or FDA (510 (k)) is desirable but not a must have
- Good oral and written communication skills in English. Knowledge in German or other languages is welcome
- Team player, pro-active and flexible personality