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.

Job