Offre d'emploi n° 2663199

Chargée d'affaires règlementaire dans les DM

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

Publiée le 29 / 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 (Bertrand and DMOS laws) through internal and external processes
- 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% :
- Develop and set up tools and service to support the customers to get their ISO 15189.
- Support and drive the implementation of accreditations for laboratories according to Governmental policy
- Create, organize and track the documentation around the products (staff training / validation of the instruments and kits)
- Communicate and sensitize the sales teams to the quality approach and to the promotion of the offer
- Promote the accreditation offer on front-sale

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