3 months ago
Hamlyn Williams has partnered with a well known Medical device company in the Berlin area that is looking for a Regulatory Affairs Manager to join their team.
The role involves but is not limited to:
- Line management you will be managing a team of 4
- Supporting with internal and external audits (authorities, notified bodies)
- Registering the products in the selected markets
- Ensuring compliance to IS0 14971, ISO 9001 and ISO 13485
- Liasing with Regulatory and Quality contacts in EMEA to requirements for the region are met
As a Regulatory Affairs Manager you will need:
- Medical device background (experience with class 3 will be advantageous)
- Vast experience with Regulatory Affairs specifically FDA 510k submissions
- Risk management experience
- Line management experience
- Fluent in German
This is a rapidly expanding Medical Device company that offers an opportunity to work with life saving products. If you are interested in accelerating your career by choosing a management position it will be great to apply and we will get in touch with you shortly to discuss the position, company, and how we can help you.