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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.
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.
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 +
Les offres de stage ou de contrat sont définies par les recruteurs eux-mêmes.
En sa qualité d’hébergeur dans le cadre du dispositif des « 100 000 stages », la Région Île-de-France est soumise à un régime de responsabilité atténuée prévu aux articles 6.I.2 et suivants de la loi n°2204-575 du 21 juin 2004 sur la confiance dans l’économie numérique.
La Région Île-de-France ne saurait être tenue responsable du contenu des offres.
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EmployeurIntelligence Anesthesia
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Secteur d’activité de la structureSanté - Social - Citoyenneté - Sécurité
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Effectif de la structureDe 0 à 10 salariés
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Site internet de la structurehttps://www.ianesthesie.com
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Type de stage ou contratContrat d'apprentissage
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Date prévisionnelle de démarrage
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Durée du stage ou contratSupérieur à 6 mois
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Le stage est-il rémunéré ?Oui
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Niveau de qualification requis
Bac + 4/5 et + -
Lieu du stageEspace co-working - Nuage Café
14 Rue des Carmes
75005 PARIS 5E ARRONDISSEMENT -
Accès et transportsRER Port-Royal