RAQM Manager

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 Hollie Barry for further details: hollie.barry@adaptivelifescience.com