Offre d'emploi n° 2632432

Regulatory Affairs & Accreditation Project Leader

Type de contrat : CDI
Localisation : Essonne
Entreprise : Nonstop Recruitment
Fonction : Santé - Social

Publiée le 27 / 06 / 2018
Expérience souhaitée : Moins de 1 an
Niveau d'études souhaité : Bac +5 et plus

Description du poste

- QA 20% : Participate in the development of the Group's Quality Management System in Europe based on the ISO 9001 and the ISO 13485; and implement this QMS in France
- RA 40% : Be the referent for Regulatory Affairs in France : tender support, regulatory monitoring, …
- (20% of the RA time) Guarantee the compliance to the "French Sunshine Act" Law

- Validate the promotional material in compliance with the ANSM rules
- Communication with the authorities especially during Reactovigilance case
- Responsible of the delivery of all official document (Sole certificate, Agreements, …)
- Tender support
- Regulatory monitoring and join SIDIV groups
- Accreditation and ISO 15189 support 40%

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