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!
Focuses:
- 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
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