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