Senior RA Officer

vor 3 Wochen

Genève, Schweiz Axepta SA Vollzeit
Senior RA Officer (US)

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



  • Senior Regulatory Affairs Officer

    vor 2 Monaten

    Genève, Schweiz Teoxane SA Vollzeit

    Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore...

  • Senior Regulatory Affairs Officer

    vor 3 Wochen

    Genève, Schweiz Teoxane SA Vollzeit

    Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore...

  • Senior Office Manager

    vor 2 Wochen

    Genève, Schweiz Page Group Switzerland Vollzeit

    Our client, a leading international trading company, is looking for a proactive and organized Senior Office Manager fluent in French and English to join their team in Geneva. The position is temporary for 3 months, with the potential for a permanent role. The candidate will need to be on-site daily to ensure the smooth operation of the office. Senior Office...

  • Senior Officer

    Vor 6 Tagen

    Genève, Schweiz AXEPTA SA Vollzeit

    Au sein de l'équipe du Middle Office, vous serez responsable de l'activité titres de la banque. Vous serez le principal point de contact pour toutes les questions opérationnelles liées aux titres.Senior Officer - Middle Office Responsabilités :Gérer et contrôler les opérations sur titres.Passer, enregistrer et surveiller les transactions sur les...

  • Senior Trust Officer

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust Officer - Relationship ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also...

  • Senior Officer

    Vor 7 Tagen

    Genève, Schweiz AXEPTA SA Vollzeit

    Au sein de l'équipe du Middle Office, vous serez responsable de l'activité titres de la banque. Vous serez le principal point de contact pour toutes les questions opérationnelles liées aux titres.Senior Officer - Middle Office Responsabilités :Gérer et contrôler les opérations sur titres.Passer,...

  • Senior Office Manager

    vor 3 Wochen

    Genève, Schweiz Page Group Switzerland Vollzeit

    Our client, a leading international trading company, is looking for a proactive and organized Senior Office Manager fluent in French and English to join their team in Geneva. The position is temporary for 3 months, with the potential for a permanent role. The candidate will need to be on-site daily to ensure the smooth operation of the office. Senior Office...

  • Senior Officer

    Vor 5 Tagen

    Genève, Schweiz AXEPTA SA Vollzeit

     Responsabilités :Gérer et contrôler les opérations sur titres.Passer, enregistrer et surveiller les transactions sur les fonds (fonds mutuels et alternatifs).Donner des instructions et surveiller les actions corporatives sur les titres non cotés.Calculer, ajuster et vérifier la précision des évaluations des titres.Réconcilier les positions de...

  • Senior Officer

    Vor 6 Tagen

    Genève, Schweiz AXEPTA SA Vollzeit

      Responsabilités : Gérer et contrôler les opérations sur titres. Passer, enregistrer et surveiller les transactions sur les fonds (fonds mutuels et alternatifs). Donner des instructions et surveiller les actions corporatives sur les titres non cotés. Calculer, ajuster et vérifier la précision des...

  • Senior Trust Manager

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust Officer - Relationship ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also...

  • Senior Trust Manager

    vor 4 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also welcome. They work to...

  • Senior Trust Manager

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also welcome. They work to high...

  • Senior Trust Manager

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also welcome. They work to high...

  • Senior Trust Manager

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Trust ManagerClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas are also welcome. They work to...

  • Senior Relationship Manager

    vor 1 Monat

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas...

  • Senior Relationship Manager

    vor 1 Monat

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own...

  • Senior Private Banking Assistant

    vor 1 Monat

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Private Banking AssistantClient:A prestigious boutique financial institution with a well-established Geneva office. As part of their dynamic growth, this is the chance to join a close-knit team that thrives in a collegial and entrepreneurial environment, everyone working hard towards a common goal - clients first (private wealth management), as well...

  • Senior Private Banking Assistant

    vor 3 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Private Banking AssistantClient:A prestigious boutique financial institution with a well-established Geneva office. As part of their dynamic growth, this is the chance to join a close-knit team that thrives in a collegial and entrepreneurial environment, everyone working hard towards a common goal - clients first (private wealth management), as well...

  • Senior Private Banking Assistant

    vor 2 Wochen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Private Banking AssistantClient:A prestigious boutique financial institution with a well-established Geneva office. As part of their dynamic growth, this is the chance to join a close-knit team that thrives in a collegial and entrepreneurial environment, everyone working hard towards a common goal - clients first (private wealth management), as well...

  • Senior Executive Assistant to CEO and Board of Directors

    vor 4 Wochen

    Genève, Schweiz Page Group Switzerland Vollzeit

    We are seeking a highly skilled and experienced Senior Executive Assistant to provide comprehensive support to a CEO and Board of Directors. The ideal candidate will possess exceptional organizational and communication skills, demonstrating a high level of professionalism and confidentiality. As a Senior Executive Assistant, you will oversee a team of Office...