Senior Regulatory Affairs
Il y a 5 mois
Fondée en 2014, Sim&Cure est une start-up numérique française axée sur l'amélioration des traitements neurovasculaires de l'anévrisme cérébral avec une suite logicielle propriétaire. Le logiciel Sim&Size est un dispositif médical de classe II avec marquage CE et autorisation de la FDA qui a déjà été utilisé pour traiter plus de 10000+ patients dans 500+ hôpitaux dans le monde.
À travers plusieurs modules, Sim&Size est une suite logicielle qui fournit au médecin une visualisation 3D des images médicales et un modèle de calcul des dispositifs médicaux implantables (DMI) neurovasculaires. La stratégie thérapeutique est l'étape la plus importante du traitement de cette maladie et Sim&Size en fait désormais partie en étant efficace, sûr et reproductible. La modélisation computationnelle de dispositifs spécifiques dans l'anatomie d'un patient aide le médecin à obtenir le résultat escompté de l'intervention.
Avantages:
- RTT
- Mutual insurance
- Meal voucher
- Company savings plan
- Gift vouchers
Finalité du poste : Assurer le maintien de la conformité du Système de Management Qualité (SMQ) et des produits aux exigences normatives et réglementaires applicables. Obtenir et maintenir les autorisations nécessaires pour la mise sur le marché des logiciels développés par la société dans les différents territoires.
Missions:
Au sein du Département Affaires Réglementaires et Assurance Qualité et sous la responsabilité de la direction AR&AQ vous serez en charge de:
- Assurer la conformité du SMQ et des produits aux réglementations et normes applicables
- Rédiger les dossiers, et réaliser les procédures d’enregistrements réglementaires nécessaires pour la commercialisation des produits dans différents pays selon les besoins commerciaux, et assurer leur maintien
- Evaluer les impacts des propositions de changements pour le produit sur le statut réglementaire du produit, et la conformité aux réglementations et normes applicables
- Maintenir le dossier technique pour le marquage CE et le dossier de conception en collaboration avec les départements Conception & Développement et Validation clinique.
- Gérer la communication avec le représentant autorisé et/ou les autorités compétentes, en particulier pour les procédures d’enregistrement produit, et en cas de report d’incident
- Réaliser la veille réglementaire
- Analyser les nouvelles exigences réglementaires et normatives pour identifier les écarts. Identifier avec les équipes concernées les actions à mettre en œuvre, et assurer le suivi de leur implémentation
- Assurer la rédaction et la mise à jour des documents du système qualité en lien avec les activités réglementaires
- Vérifier la conformité réglementaire des supports promotionnels avant leur diffusion
Cette liste est non exhaustive et peut évoluer en fonction du contexte et de la stratégie d'entreprise.
Qualifications:
- Bac+5 (Master) en Affaires réglementaires des produits de santé
- Une première expérience (minimum 2 ans) réussie dans l’industrie des dispositifs médicaux.
- Bonne connaissance des réglementations Européennes relatives aux dispositifs médicaux Directive 93/42/EEC, MDR 2017/745, et de la réglementation américaine (21CFR)
- Maitrise des processus de marquage CE des dispositifs médicaux et de ‘premarket notification 510k’
- Connaissance souhaitée des normes ISO 62304, ISO 14971, ISO 62366 et ISO 13485.
- La connaissance du processus du cycle de vie d’un logiciel dispositif médical est un plus
- Bon niveau d’anglais écrit et oral (niveau minimum B1)
- Capacité d’analyse et de synthèse
- Rigueur et autonomie
- Compétences organisationnelles
- Capacité à travailler en équipe, en mode projet
- Excellente communication
- Maitrise de la suite Office
4+ years
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