Medical Devices Project Manager

il y a 1 semaine


Thionville, Grand Est, France RH Lab. Temps plein
Mission

Notre client, RH Lab., spécialiste dans les solutions cosmétiques, recherche un(e) Medical Devices Project Manager pour renforcer ses équipes.

Responsabilités
  • Collaborer avec différents services à la conception et au développement de nouveaux dispositifs médicaux.
  • Coordonner les activités de recherche des parties internes et externes pour assurer l'exécution du projet dans les délais impartis.
  • Préparer des rapports de projet pour le directeur général et la direction.
  • Suggérer des domaines de recherche et des idées de nouveaux produits pour les nouveaux dispositifs médicaux.
  • Préparer et soumettre le dossier technique des dispositifs médicaux de classe 3.
  • Superviser toutes les étapes du développement du produit, telles que l'étude de l'état de l'art, le développement de prototypes, les études de durée de conservation, les recherches précliniques et cliniques, etc.
  • Superviser les essais, la correction et la validation de l'efficacité, de la sécurité et de la stabilité des dispositifs médicaux.
  • Contribuer à la préparation de rapports techniques, de documentation et d'analyses industrielles.
  • Contrôler et superviser les études scientifiques et cliniques, la recherche et les essais de produits dans le respect de la réglementation.
  • Rédiger les documents nécessaires à l'enregistrement et à la production de documents.
  • Être responsable de la rédaction et de la soumission des certifications de produits.
  • Superviser et coordonner l'enregistrement de nouveaux dispositifs médicaux.
Compétences requises
  • Titulaire d'un Master en Pharmacie, Chimie, Biochimie ou dans un domaine connexe.
  • Expérience de 5 ans minimum dans un domaine similaire, de préférence dans l'industrie cosmétique.
  • Certifications pour les formations réglementaires.
  • Connaissance des normes réglementaires relatives aux essais cliniques et à la sécurité des produits médicaux.
  • Connaissance des normes ISO 13485.
  • Excellentes aptitudes à la communication et à la collaboration.
  • Volonté de travailler au sein d'une équipe et de soutenir une entreprise en pleine croissance.
  • Excellente maîtrise de l'anglais, tant à l'écrit qu'à l'oral, obligatoire.
  • Le français ou toute autre langue est un atout.
Conditions et Avantages
  • Prise de fonction immédiate ou à convenir.
  • CDI à temps plein.
  • Rémunération selon profil et expérience.

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