Senior RA Officer

vor 3 Wochen


Geneva, Schweiz Axepta SA Vollzeit

Notre client, une entreprise internationale en pleine expansion spécialisée dans les dispositifs médicaux, recherche actuellement un Chargé(e) d'Affaires Réglementaires Senior (US) pour renforcer son équipe basée à Genève. 

 

VOS RESPONSABILITÉS :

  • Contribuer à l'élaboration de la stratégie réglementaire dans le cadre du développement de nouveaux produits en collaboration avec les départements internes.
  • Superviser la compilation des dossiers de soumission réglementaire pendant le développement/l'enregistrement du produit pour garantir des soumissions/approbations en temps imparti.
  • Participer à l'examen des réponses aux questions posées par la FDA afin de garantir des réponses appropriées, cohérentes et complètes.
  • Soutenir les activités de gestion du cycle de vie.
  • Diriger la préparation des dossiers d'information pour les interactions avec la FDA.
  • Revoir la partie labelling, participer aux audits et inspections et à la stratégie réglementaire avec les intervenants externes.
  • Gérer la base de données réglementaires.
  • Maintenir les SOP du département réglementaire.
  • Exécuter toute autre mission spécifique qui pourrait vous être confiée par la Direction.

VOTRE PROFIL :

  • Expérience d'au moins 7 ans dans les affaires réglementaires au sein de l'industrie des dispositifs médicaux 
  • Très bonne connaissance de la réglementation américaine, de la norme ISO 13485, 21CFR part 820, MDR 2017/745 
  • Expérience avérée avec les authorités de santé (US, EU)
  • Expérience avérée en soumission de dossier complexe 
  • Capacité à évoluer dans un environnement dynamique.
  • Maîtrise du français avec au moins un niveau B2 en anglais.
  • Bon esprit d'équipe.


Branche: Medizin/Krankenhaus

Funktion: Anderes

Anstellungsart: Festanstellung





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