Product Safety Specialist

il y a 2 semaines

Le PontdeClaix, Auvergne-Rhône-Alpes, France BD Temps plein
**Job Description Summary**: Avec plus de 75000 collaborateurs dans le monde, des talents, des savoir-faire au service de la santé, un marché en forte expansion, BD, fabricant et distributeur de dispositifs médicaux et de matériels de diagnostic est une référence incontournable du monde médical.

Le site de Pont de Claix, près de Grenoble, regroupe le siège mondial de l'unité Pharmaceutical Systems, une unité de production parmi les 6 sites de production mondiaux (France, UK, Singapour, Japon, US, Mexique) et le marché Français pour les autres unités du groupe BD. Notre offre comprend un vaste portefeuille de seringues préremplies, de systèmes d'auto-injection, de solutions de sécurité et de protection.

C'est vous qui pouvez faire la différence. Rejoignez-nous et jouez un rôle crucial dans l'avancement du monde de la santé

Rattaché(e) à l'organisation globale des Affaires Médicales de l'entité Pharmaceutical Systems votre mission sera de contribuer à la sûreté de nos produits (seringues préremplies et auto injecteurs) et à la gestion des risques depuis la conception des produits jusqu'à la fin de leur cycle de vie sur un plan scientifique et de la sécurité patient.

**Missions principales**
- Etre l'interlocuteur/trice sur les sujets liés à la sécurité des produits (ISO10993, y compris l'évaluation de l'extractible, ISO14971 & matériaux préoccupants) pour les projets sous votre responsabilités
- S'assurer d'être à jour de tous les changements (processus, fabrication, fournisseur...) afin de pouvoir mener les évaluations scientifiques appropriées.
- Réaliser les tests précliniques requis pour évaluer la surêté de nos produits en conformité avec les normes, les directives et les règlementations applicables.
- Formuler des conclusions sur les éventuels risques résiduels en matière de toxicologie/biocompatibilité en fonction des utilisations prévues pour tous les produits, en étroite relation avec les procédures de gestion des risques.
- Apporter des réponses internes ou externes dans le cadre du processus de demande de sécurité des produits (contributions médicales ou de sécurité aux plaintes des clients, soutien aux affaires réglementaires sur nos dossiers, réponses aux demandes des clients/autorités, actions d'amélioration continue, évaluation de l'impact des CAPA, déviations sur la sécurité des patients ou des utilisateurs finaux, impact des nouvelles réglementations).

**A propos de vous**

Issu(e) d'une formation scientifique (PhD, PharmD, Ingénieur ou Master), vous possédez une première expérience idéalement acquise dans l'industrie pharmaceutique ou du dispositif médical et avez également de bonnes notions en gestion de projet.

Habitué(e) aux environnements réglementaires de type pharma et/ou du dispositif médical, vous avez idéalement des connaissances de la norme ISO10993, des évaluations biologiques ou de la toxicolgie.

Vous possédez d'excellentes aptitudes pour les relations interpersonnelles, la communication et le travail d'équipe dans un environnement cross fonctionnel et multiculturel.

Vous avez un niveau d'anglais courant vous permettant d'échanger quotidiennement dans un environnement professionnel international.

**Depuis plus de 120 ans, BD **accompagne soignants et patients, **partout, tout le temps, **venez nous rejoindre pour vivre une opportunité exceptionnelle au sein d'une entreprise en croissance et axée sur des valeurs humaines fortes.

**Primary Work Location**: FRA Le Pont-de-Claix Cedex

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