Description

Entreprise :

Our client is an international company specialized in medical devices.

Description du poste :

* Technical documentation writing management (for Europe & the US);
* Involvement in the development and design of the company's medical devices;
* Risk management, from the early life of each device;
* Review and approval of validation and verification documents;
* Acting as Process Owner;
* Contribution to internal & external audits;
* Ensure strong collaboration with other teams, and supporting them in QA/RA trainings.

Description du profil :

* Minimum 3 years of experience within the medical device industry;
* Strong knowledge of ISO 13485, ISO 14971, 21 CFR, MDR;
* Experience with submitting technical files for Europe & the US;
* French and English are mandatory.