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Job

Regulatory Affairs Manager

  • Location

    Berlin

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Leah James

  • Contact email:

    l.james@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2021-03-11

  • Startdate:

    ASAP

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.