Regulatory Affairs Manager H/F

Updated: April 12, 2024 02:47 PM GMT

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We are looking for a Regulatory Affairs Manager, on behalf of an international client company based in Haute-Savoie (France) and specialized in injectable medical devices. Attached to the Quality, Regulatory, and Clinical Director, you will BE responsible for regulatory affairs management throughout the product lifecycle, from conception to market monitoring.

Your main missions are as follow :
- Manage the Regulatory Affairs team and coordinate activities.
- Ensure regulatory and normative monitoring :
- Ensure regulatory and normative monitoring of products distributed in Europe and internationally,
- Identify the list of standards/regulations applicable to activity and verify their consideration,
- Coordinate monitoring activities with other functions within the company.
- Manage CE Marking files :
- Draft technical CE Marking files and make market placement declarations,
- Ensure the technical file is kept up to date,
- Ensure post-CE marking maintenance of... More Detail