International Regulatory Affairs Manager (m/w/d)
The location specified in the vacancy (Aschau, Erfurt or remote) is discussed based on where the candidate lives. Initial training lasts 6 weeks and is held at the main site.
Your tasks
- International approval of medical devices according to country-specific guidelines and laws
- Upkeeping existing approvals
- Communication and contact with internal partners, retailers and external advisers
- Preparing and drafting marketing authorisation documents for internal product approvals
- Coordinating activities in close collaboration with internal departments (RA national, Export, etc.).
- Monitoring and implementing national and international regulatory requirements
Your requirements
- Completed technical education + further education, alternative; Technical or science degree
- We welcome candidates who have trained as a Regulatory Affairs Manager
- Experience in the field of Regulatory Affairs and affinity in working with regulatory requirements
- Ability to communicate with a range of partners on legally binding matters
- Good written and spoken English
- Familiar with MS office package
- Highly motivated and flexible team player
- Pragmatic and analytical approach
- Confident
- Conscientious and structured approach
We offer
As a reliable employer we support our Königsee team with a host of prospects and flexible offers for all phases in life. Discover us:
- A structured and detailed initiation at the company sites where a mentor will support you.
- Varied and responsible tasks including decision pathways and a flat hierarchy
- A future-proof and permanent job in a growing company
- A family-oriented and social personnel policy, incorporating flexible working hours, for instance, ensures a healthy work-life balance
- Sustainability and responsibility for future generations is incorporated into the day-to-day running of the business
- Open company structure
- Free parking
- Water dispensers
- Monthly vouchers
- Company pension
- …. And much more
Please email your applications with your salary expectations electronically only to Ms Höpping-Schwenk: bewerbung@koenigsee-implantate.de
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