IVD RAQM Manager

  • Location


  • Sector:

    Quality, Regulatory Affairs

  • Salary:

    60,000EUR - 70,000EUR plus stock options

  • Contact:

    Rebecca Stevens

  • Job ref:


Quality & Regulatory Affairs Manager

Are you a professional in RAQM, searching for a new opportunity where you can really have a seat at the table?

Would you enjoy having the flexibility to delve into new topics and learn new skills, working in a global quality and regulatory affairs position?

We are supporting our client in Berlin, an exciting team who are paving the way in women’s healthcare technology, as they search for a Quality & Regulatory Affairs Manager to join them on their mission!

  • Creation and further development of regulatory strategies (focus on EU and FDA)
  • Handling communication with Notified Body and authorities
  • Generation and maintenance of technical documentation
  • Implementation and maintenance of the Quality Management System, in accordance with ISO 13485, IVDR and FDA 510(k)
  • Supporting during audits (internal and external)
  • Ensuring all processes and products are compliant and meet all necessary requirements

Experience required:
  • A degree in the medical/engineering field
  • 5+ years of experience in Regulatory Affairs/Quality Management (within the medical device/in-vitro diagnostic sector)
  • Knowledge of regulatory requirements and medical device standards (e.g. ISO 13485 EU-MDR, FDA, ISO 14971, IEC 62304)
  • Experience with the creation of technical files
  • Fluency in English, and a professional level of German

If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com