QMBOur client is a leader in the field of repetitive magnetic stimulation with a focus on neurostimulators. They are truly committed to guarantee the satisfaction of their customers with the quality, functionality and technology. To ensure the the highest standard in quality they are now in the need of Quality Management Representative.
- Creation and maintenance of technical documentation for Class I-IIa medical devices including embedded software and electrical components (in accordance with EN 60601 & IEC 62304
- Continuous improvement of the quality management system in accordance with ISO 13485 and MDR requirements
- Coordination of global registration and market entry in other countries (FDA, MDR)
- Providing the guidance and training to colleagues on regulatory compliance and quality management.
- Successfully completed technical or scientific studies or comparable qualification.
- Several years of experience in the field of quality management & 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