Regulatory Affairs Manager

  • Location

    Freiburg, Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    70,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    21371

Our client has a patient-centric culture, offices in Freiburg, and are developing medical devices for neurological conditions and surgeries. Every day, their work makes neurosurgery safer and more efficient, and their RAQM team need your support. You’ll help their products reach more patients globally and improve the quality of their lives as a Global Regulatory affairs Specialist/Manager.

 

Your responsibilities:

  • Coordination and preparation of approvals for our DORO® medical products worldwide (focus on USA and EU)
  • Monitoring of existing approvals and project planning to maintain them
  • Coordination of registration priorities with sales
  • Monitoring of the current and new regulatory requirements and standards and reporting of these to the management
  • Further development of the approval strategy worldwide

 

Your Experience:

 

  • Successful completion of degree in medical technology or related subjects.
  • Experience in the field of approval for medical devices worldwide.
  • Working knowledge of FDA 510k as well as EU MDR.
  • Previous experience liaising with Notified body and other health authorities

 

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

Kasia.Krasuska@Adaptivelifescience.com

+44 208 133 5376