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Regulatory & market Access Specialist
vor 1 Woche
Notre client, une entreprise spécialisée dans les dispositifs médicaux et avec une très bonne réputation recherche actuellement un Regulatory & Market Access Specialist afin d'agrandir son équipe sur le canton de Genève.
Regulatory & market Access Specialist
VOS RESPONSABILITES:
Gérer les activités réglementaires nécessaires pour la mise sur le marché des dispositifs médicaux et le maintien des enregistrements à l'échelle mondiale.
Travailler avec les autres départements ( R&D, Qualité, ...) pour gérer les dossiers d'enregistrement et l'impact réglementaire des changements et transferts.
Collaborer avec partenaires externes pour surveiller et gérer le cycle de vie des enregistrements au niveau global.
Collaborer avec les Affaires Cliniques et Scientifiques pour répondre aux questions des autorités de santé.
Soutenir la préparation et le maintien des dossiers d'enregistrement ainsi que la base de données.
Participer à la rédaction et à la mise à jour de la Documentation MDR et à la rédaction de 510(k)
Soutenir la préparation des rapports PMS/PSUR pour les produits.
Participer aux audits internes et externes.
Gérer les KPIs sur votre partie.
VOTRE PROFIL :
Master en market access, affaires réglementaires ou autre diplôme similaire avec une expérience de 2/3 ans sur un poste similaire.
Bonne connaissance dans les réglementations des dispositifs médicaux (MDR, ISO 13485), expérience FDA serait un plus.
Précédente expérience de mise sur le marché de dispositifs médicaux et gestion du cycle de vie des dispositifs médicaux.
Bonne esprit d'équipe et de collaboration.
Français et anglais courant
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