Regulatory Affairs Manager

  • Location

    Berlin, Germany

  • Sector:

    Regulatory Affairs

  • Salary:


  • Contact:

    Rebecca Stevens

  • Job ref:


  • Published:

    about 2 months ago

  • Expiry date:


Regulatory Affairs Manager

Our client is a start-up, specializing in breast cancer detection. Their aim is to to enable more successful treatment options and increase women’s chances of survival.

To ensure that their product gets to the market the are now in a need of Regulatory Affairs Manager.

Your responsibilities:

  • Introduce our client’s software to new international markets.
  • Design, maintain and monitor all processes in accordance with ISO 13485.
  • Liaise with the Notified Body and other health authorities.
  • Take responsibility for risk management activities in accordance with ISO 14971.

Experience required:

  • Successfully completed technical or scientific studies or comparable qualification.
  • Experience in working with ISO 13485, preferably in the area of SaMD.
  • Working knowledge of the legal requirements for medical devices, such as : MDR, ISO 14971 or IEC 62304.
  • Excellent oral and written communication skills.

Please apply with your CV or contact Kasia Krasuska for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

+49 30 16 63 83 76