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Regulatory & market Access Specialist
vor 4 Monaten
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
