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Quality & Regulatory Affairs Specialist (H/F)

Il y a 4 mois

Paris Opéra, Île-de-France Posos Temps plein
**Notre mission** : aider les professionnels de santé à mieux soigner en apportant la connaissance médicale la plus adaptée pour chaque patient.

Posos est **le premier outil d'aide à la décision thérapeutique** capable de croiser instantanément les informations de 170 sources sur les médicaments, pathologies avec les données du patient. Le moteur d'intelligence artificielle de Posos comprend la question du soignant dans ses propres mots et lui apporte une réponse contextualisée qui l'aide à choisir **le meilleur traitement pour ses patients**.

Créée en 2017, Posos est utilisée par plus de **45 000** professionnels de santé, dont plus de **20 000** médecins en France.

**Rattaché(e) au Pôle Qualité et Réglementaire et sous la direction du Head of Quality & Regulatory Affairs vos principaux rôles sont les suivants**:
**Qualité**:

- Maintien et amélioration du Système Management de la Qualité
- Participation aux audits de certifications et de conformité
- Diffuser une culture et une démarche qualité au sein de l'entreprise

**Réglementaire**:

- Rédaction des dossiers de marquage CE sous RDM 2017/745
- Gérer l'ensemble de la partie post-market surveillance, assurant le suivi des produits après leur mise sur le marché
- Élaborer et mettre en œuvre la stratégie d'évaluation clinique, garantissant la conformité aux exigences réglementaires.
- Accompagner le lancement de nouvelles solutions

Pour les profils plus orientés ingénieur, des missions en lien avec l'amélioration et le développement des outils du Système de Management de la Qualité (SMQ) pourront être proposées

D'autres **projets qualité & réglementaire** vous attendent, ainsi que de nombreuses participations à des évènements.

**Profil recherché**
- Diplômé d'un master spécialisé en ingénierie, affaires réglementaires, dispositifs médicaux, pharmacie ou qualité.
- Connaissance approfondie du Règlement 2017/745 et des différentes normes relatives aux logiciels pour dispositifs médicaux, notamment l'ISO 13485.
- Première expérience dans les domaines des Affaires Réglementaires ou de la qualité pour les dispositifs médicaux.
- Motivé(e) par la vie en start-up, vous êtes rigoureux(se) et autonome dans votre travail. Vous travaillerez en étroite collaboration avec l'équipe, mais vous devrez également développer rapidement une forte autonomie sur vos projets. Vous devez être capable de gérer plusieurs tâches en parallèle dans un environnement en évolution.

**Déroulement des entretiens**
- Entretien avec le CEO pour évaluer l'adéquation avec la vision de l'entreprise.

Type d'emploi : Temps plein, CDI
Statut : Cadre

Salaire : 40 000,00€ à 44 000,00€ par an

Avantages:

- Prise en charge du transport quotidien
- RTT
- Titre-restaurant
- Travail à domicile

Programmation:

- Du lundi au vendredi
- Travail en journée

Lieu du poste : Hybrid remote Paris 9e)

Date de début prévue : 15/09/2023