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.