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.
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
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.
+49 30 16 63 83 76