Regulatory Affairs Manager Medical Devices

Vor 2 Tagen


Geneve, Schweiz Axepta SA Vollzeit

Nous recherchons actuellement un **Responsable Affaires Règlementaires **pour l'un de nos plus prestigieux clients, afin de diriger son équipe réglementaire dans leurs activités pour l'enregistrement des produits à l'internationale.

Rejoignez une entreprise de renommée mondiale, en pleine croissance et spécialisée dans les dispositifs médicaux, basée à Genève.

**Responsabilités**:

- Participer à la définition et la mise en place de la stratégie réglementaire pour le développement de nouveaux produits.
- Assurer la maintenance et l'optimisation des processus et procédures réglementaires.
- Manager une équipe réglementaire d'environ 5 personnes dans ses activités, définir leurs objectifs et les soutenir au quotidien.
- Contrôler la documentation réglementaire et les dossiers techniques pour les enregistrements et soumissions en Europe et aux US.
- Répondre aux différentes questions des autorités réglementaires et organismes notifiés
- Superviser le Change Control
- Assurer la veille réglementaire à l'international
**Votre profile**:

- Vous justifiez nécessairement d'au moins 8 ans d'expérience dans les affaires réglementaires pour les Dispositifs Médicaux à un niveau international, et avec a mínima une première expérience pour le management d'une équipe réglementaire.
- Expertise des normes et réglementations applicables aux DM en Europe et aux US (GMP, ISO13485, 21CFR820...).
- Français et Anglais courant exigé.

Pour plus d'informations, n'hésitez pas à contacter Morgane CAYUELA



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