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Job

Senior Regulatory Affairs Specialist

  • Location

    Karlsruhe

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Leah James

  • Contact email:

    l.james@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    8 months ago

  • Expiry date:

    2021-01-09

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a rapidly expanding Medical device company that is looking for a Regulatory Affairs Specialist to join their team. This position gives you the chance to work with High risk class 3 products 

The role will involve:

  • Creating, submitting, and maintaining national international Product registrations 

  • Supporting with internal and external audits (authorities, notified bodies) 

  • Registering the products in the selected markets ]
  • Cross-team collaboration on projects within other departments 

As a Regulatory Affair Specialist you will need:

  • Medical device background
  • Experience with Regulatory affairs 
  • MDR knowledge and experience 
  • ISO13485 experience  

I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at l.james@hamlynwilliams.com