Regulatory Affairs Manager
Il y a 2 mois
IT&M Stats intervient dans le domaine des statistiques, de la programmation et de la data science, principalement dans les secteurs de l’Industrie Pharmaceutique, Cosmétique, dans la Santé et l’Agro-alimentaire. IT&M Stats est une filiale du Groupe Astek, acteur mondial de l’ingénierie et du conseil en technologies.
Nous basons notre relation sur :
- Un respect des collaborateurs et des clients, de leurs aspirations,
- Un suivi personnalisé des collaborateurs et des clients,
- Une gestion régulière des carrières des collaborateurs,
- Des échanges transparents,
- Une réactivité, une disponibilité et une écoute permanentes.
Nous recherchons un Regulatory Affairs Manager afin de garantir la conformité réglementaire des dispositifs médicaux en France, en Europe et à l'international.
Missions principales
- Rédiger et soumettre les dossiers d'inscription ou de renouvellement aux autorités compétentes.
- Assurer la communication avec les organismes notifiés et les autorités réglementaires.
- Participer à l'élaboration et à la mise en œuvre des stratégies opérationnelles et des plans d'actions.
- Préparer et actualiser la documentation technique des dispositifs médicaux, notamment en conformité avec les règlements MDR et IVDR.
- Valider les documents (procédures, documents marketing, manuels d'utilisation, etc.) pour garantir leur conformité aux réglementations et normes nationales et internationales.
- Servir de point de contact pour les employés et partenaires commerciaux en matière de réglementation des dispositifs médicaux de la Business Unit.
- Coordonner des audits, inspections des organismes de réglementation et rappels de produits, en collaboration étroite avec le QA Manager Diagnostics.
- Assurer une veille réglementaire active et à jour, en identifiant les impacts potentiels des nouvelles réglementations.
- Conseiller, former et sensibiliser les équipes internes sur les enjeux réglementaires.
- Mettre à jour et gérer les bases de données réglementaires (telles que EUDAMED).
- Superviser et suivre les actions de vigilance, les rappels et les rapports aux organismes notifiés si nécessaire.
Vous pensez être la perle rare ?
● De formation pharmacien ou master en sciences
● Expérience d’au moins 5 ans dans les Affaires Réglementaires des dispositifs médicaux
● Vous avez une expertise en réglementation européenne et internationale des dispositifs médicaux, idéalement avec une expérience confirmée de certification MDSAP
● Vous maitrisez la norme ISO 13485 et maîtrisez les outils du pack Microsoft Office (Word, Excel et Powerpoint).
● Fluent anglais
Voici ce que nous pouvons vous offrir…
Un poste en CDI à pourvoir dès que possible, de la bonne humeur, des formations, des soirées, de la bienveillance, un suivi personnalisé, une gestion régulière de votre carrière, des échanges transparents et une écoute permanente.
Si vous êtes convaincu que vous êtes la perle rare, postulez Nous sommes impatients de vous rencontrer.
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