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Job

Regulatory Affairs and Clinical Research Manager

  • Location

    Munich

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Leah James

  • Contact email:

    l.james@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-04-10

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a Medical Technology company based in Munich that is in a Major phase of growth and looking for a Regulatory Affairs and Clinical Research Manager. 

The role will involve:

  • Taking a leading role in regulatory affairs and quality management

  • Be responsible for the creation and maintenance of technical documentation for  medical devices (SaMD, Class IIa) ensuring continued regulatory compliance with (EU) 2017/745 (MDR)

  • Contribute to the clinical evaluation of our software products

  •  Identify and evaluate risks in our software systems according to ISO 14971 to reduce productrelated risks to a minimum

  • Setup and implement multi-centre clinical research and validation studies and projects

As a Regulatory Affairs and Clinical Project manager you will need:

  • Experience in clinical research / project management7
  • Technical understanding and a strong interest in IT, medical device software and artificial
    intelligence
  • Excellent organizational, analytical, project management skills
  • Experience within Regulatory Affairs within the Medical device space 
  • German speaking