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Job

QA/RA specialist

  • 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:

    2021-04-25

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a Medical Device company based in Berlin that is in a Major phase of growth and looking for a Senior Quality Assurance specialist with Regulatory Affairs responsibilities.  

The role will involve:

  • Cross colabiration between teams with a strong focus on complaint handling & reporting

  • Establishing implementing  and maintaining  processes to comply with regulatory requirements according to MDR 
  • Active involvement in investigations into  quality and regulatory related issues including performing root cause analysis, and implementation of preventive and corrective actions
  •  Be responsible for the creation and maintenance of technical documentation for the class 2 medical devices ensuring continued regulatory compliance with (EU) 2017/745 (MDR)

As a Senior QA specialsit you will need:

  • Medical device background 
  • Experience with CE marking and the QMS 
  • Excellent organizational, analytical, project management skills
  • Experience within Regulatory Affairs and Quality within the Medical device space 
  • German speaking

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