STAGE Business Healthcare & Quality / Regulatory Specialist - Medical Device Industr

Date de mise à jour de l’offre

Intelligence Anesthesia :

Start-up médicale développant une clinique virtuelle de préparation à la chirurgie. Enterprise: Intelligence Anesthesia’s mission is to make technological breakthrough innovations accessible to patients before surgery. To fulfill this commitment we work every day with patients & hospitals to co-build projects with real-life positive impact. Born, in 2019, out of a medical research project, our company gathers the talents of 10 team members. Our first product, the iAnesthesia platform, is a software as a medical device to automatically prepare patients before surgery, embedding artificial intelligence to automate the right preparation delivery. We aim to develop the solution in Europe & USA.

Description de la mission

Enterprise:
Intelligence Anesthesia’s mission is to make technological breakthrough innovations accessible to patients before surgery. To fulfill this commitment we work every day with patients & hospitals to co-build projects with real-life positive impact. Born, in 2019, out of a medical research project, our company gathers the talents of 10 team members. Our first product, the iAnesthesia platform, is a software as a medical device to automatically prepare patients before surgery, embedding artificial intelligence to automate the right preparation delivery. We aim to develop the solution in Europe & USA.

In order to support this strategy and the ever-growing interest around Intelligence Anesthesia and its solutions we
are looking for a Quality & Regulatory Specialist that will make available the technical know-how and product history for technical and non-technical users, manage the SMQ & participate in the global regulatory strategy (ISO 13485 & 62304)

Missions:
Manages a content management system and SMQ, Guarantees that the product documentation is understandable from every concerned department, Gathers inputs from all other departments, Ensures compliance of the product documentation with the technical documentation, Develops and sets up review and update processes for the product documentation, Manages the translation and localization workflow of the product documentation, Depending on the experience: could write, review or approve clinical or technical documentation for clinical or commercial aspects, Supports key improvement initiatives to achieve company business objectives, Helps support departments to develop and maintain a Quality-oriented culture that exceeds industry standards, Ensures own compliance with Health and safety regulations and rules.

Profil recherché

Qualifications:
Master's degree, Engineer in the scientific field or in medical care, Experience with regulated medical device environment preferred, Knowledge of medical device labeling standards (ISO 13485, IEC 62304 & 60601), English: native or bilingual proficiency, Ability to manage a content management system, Experience with limited supervision and timeline-driven environment, Managing multiple competing priorities at the same time, Excellent written and verbal communication skills.

Niveau de qualification requis

Bac + 4/5 et +
  • Employeur
    Intelligence Anesthesia
  • Secteur d’activité de la structure
    Santé - Social - Citoyenneté - Sécurité
  • Effectif de la structure
    De 0 à 10 salariés
  • Site internet de la structure
    https://www.ianesthesie.com
  • Type de stage ou contrat
    Contrat d'apprentissage
  • Date prévisionnelle de démarrage
  • Durée du stage ou contrat
    Supérieur à 6 mois
  • Le stage est-il rémunéré ?
    Oui
  • Niveau de qualification requis

    Bac + 4/5 et +
  • Lieu du stage
    Espace co-working - Nuage Café
    14 Rue des Carmes
    75005 PARIS 5E ARRONDISSEMENT
  • Accès et transports
    RER Port-Royal