Are you a professional in RAQM, searching for a new challenge?
Would you enjoy having the flexibility to delve into new topics and learn new skills, working in a global regulatory affairs position?
We are supporting our client, a leading manufacturer in the ophthalmic field, in their search for a Regulatory Affairs Manager for their site in Stuttgart.
Focuses:
- Creation and further development of national and international regulatory strategies
- Handling communication with Notified Body and authorities, as well as suppliers (win relation to approval procedures)
- Supporting with the maintenance of the post-market surveillance system
- Preparation and maintenance of risk analysis and technical documentation
- Updating of SOPs
- Supporting the Quality Management function
Experience required:
- A degree in the medical/engineering field
- 2+ years of experience in Regulatory Affairs (within the healthcare/medical device sector)
- Knowledge of regulatory requirements and medical device standards (e.g. ISO 13485 EU-MDR, ISO 14971)
- Experience with the creation of technical documentation
- Fluency in English and German
If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com
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