Regulatory Affairs Engineer
Would you like to support devices throughout the whole lifecycle, supporting with topics such as R&D, design, clinical reporting, registrations & also post-market surveillance?
We are supporting a highly innovative client in the medical device industry, who are developing products in the area of airway management, anaesthesia and ICU accessories.
Join this tight-knit, collaborative RAQM team, based in the Sulz am Neckar region!
Focuses:
- Overseeing worldwide product registrations
- Handling the creation and maintenance of technical documentation
- Support with successful entrance of products into international markets
- Supporting with conformity assessments
- Providing regulatory support throughout new product development/ product changes
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Providing support during internal and external audits
- Communication with Notified Bodies / regulatory authorities???????
Experience required:
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Knowledge of ISO 13485 and medical device standards
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2+ years of experience within Regulatory Affairs
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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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