Regulatory Affairs Manager

  • Location

    Freiburg, Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    65,000EUR - 85,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    21035

Regulatory Affairs

We are currently supporting a client in Freiburg, who is a global leader in radiation therapy and active medical devices.  

They are in the need of a Regulatory Affairs Manager to focus on their international market and approvals.

 

Your responsibilities:

  • Preparation of regulatory strategies and pans for worldwide approvals
  • Contact Liaison for internal areas such as R&D, product management and sales
  • Monitor, track and record the approval status of products worldwide and keep them up to date in an internal database
  • Independent preparation of submission documentation for the global approval of medical devices

 

Experience required:

  • Successfully completed technical or scientific studies or comparable qualification.
  • Several years of experience in the field of regulatory affairs 
  • Experience in compiling technical documentation for international approvals (ideally for LATAM, MEA, Russia/EAEU) 
  • Knowledge in the field of regulatory compliance in accordance with ISO 13485, ISO 14971 & IEC 62304.

 

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

+49 30 16 63 83 76