Regulatory & market Access Specialist

Vor 6 Tagen


Geneva, Schweiz AXEPTA SA Vollzeit

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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