Head of Regulatory Affairs Eu and Us Medical Devices

vor 3 Wochen

Fribourg, Schweiz Axepta SA Vollzeit

Notre client, une société de dispositifs médicaux de niche en pleine croissance, recherche un Head of Regulatory Affairs (QP) EU et US pour rejoindre son bureau de Genève.

Cette position offre une expertise stratégique et un leadership à ses partenaires commerciaux et parties prenantes (y compris la R&D, la Clinique, la Qualité et le Marketing).

**Responsabilités**:

- Élaborer la feuille de route stratégique réglementaire selon les objectifs commerciaux et fournir un leadership réglementaire pour les programmes dans l'espace pré et post-marché.
- Fournir un mentorat stratégique pour garantir l'alignement des stratégies réglementaires avec les objectifs commerciaux et la mise en ?uvre des plans stratégiques.
- Contribuer aux décisions stratégiques clés impactant le développement des processus et procédures de conformité réglementaire globale.
- Suivre la mise en ?uvre des nouvelles exigences de l'UE et des États-Unis à travers le processus d'intelligence réglementaire et adapter la stratégie en conséquence.
- Contribuer à la stratégie réglementaire dans le cadre du développement de nouveaux produits en collaboration avec des équipes pluridisciplinaires en définissant les voies réglementaires et en développant des stratégies réglementaires pour soumission aux Organismes Notifiés et à la FDA.
- Superviser la compilation des dossiers de soumission réglementaire pour les nouveaux produits et les modifications de produits pour obtenir des soumissions/approbations en temps opportun (y compris les IDE et les PMA).
- Contribuer et examiner les réponses aux questions posées par l'Organisme Notifié et la FDA pour garantir des réponses appropriées, cohérentes et complètes à toute question.
- Soutenir les activités de gestion du cycle de vie (y compris l'évaluation de l'impact réglementaire des changements de contrôle pour les régions de l'UE et des États-Unis).
- Garantir la conformité des produits avec les réglementations et normes de l'UE et des États-Unis.
- Garantir l'excellence des Affaires Réglementaires en soutenant l'établissement, la maintenance et l'optimisation des processus et procédures des Affaires Réglementaires afin d'assurer l'amélioration continue du QMS
- Assurer une communication efficace au sein de l'équipe mondiale des Affaires Réglementaires.
- Mentorer, former, superviser l'équipe des Affaires Réglementaires dédiée aux régions de l'UE et des États-Unis en les habilitant à interagir et à négocier avec les régulateurs.

**Exigences et compétences**:

- Diplôme et l'expérience pour agir en tant que Deputy PRRC.
- Minimum 10 ans d'expérience dans des fonctions similaires.
- Expérience en Affaires Réglementaires dans le domaine des dispositifs médicaux (dispositifs médicaux à haut risque) avec une connaissance approfondie des réglementations de l'UE et des États-Unis et un fort leadership avec au moins une expérience de gestion d'équipe.
- Grande capacité à prendre en charge et à assumer la responsabilité des actions.
- Capacité à résoudre les problèmes et à prendre des décisions réglementaires.
- Expérience dans la négociation avec les agences réglementaires et l'Organisme Notifié.
- Démontrer des compétences pour gérer plusieurs projets simultanément.
- Capacité à travailler dans un environnement dynamique.
- Parle couramment anglais et français

Branche: Medizin/Krankenhaus

Funktion: Qualitätsprüfung

Führungsperson: Ja

Anstellungsart: Festanstellung

Karrierestufe: Management

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