Quality & Regulatory Affairs Specialist
Are you motivated to be part of a company whose aim is to save lives through their innovation? Would you be interested to work internationally with both hardware and app-based medical devices?
We're currently supporting a highly innovative start-up based in Dresden who are searching for a passionate RAQM Specialist to join the team and provide support as they prepare to launch their products to market. This role offers huge growth potential, and you will have a voice and be able to directly impact the design, development process & market entry plans.
Focuses:
- Development and maintenance of the Quality Management System, according to ISO 1345
- Preparation of technical documentation according to MDR requirements
- Support with international approvals for medical products
- Support with CAPAs, change and risk management
- Communicating with Notified Bodies and Competent Authorities and external suppliers
- Supporting with internal and external audit processes
Experience required:
- Knowledge of ISO 13485 and experience with IEC 62304 is desirable
- 1+ years of experience within Regulatory Affairs
- Fluency in English required, fluency in German is desirable.
If you're interested in this position, please contact Kasia Krasuska for further details:
