Regulatory Affairs Specialist
Il y a 4 mois
Nous recherchons pour un fabricant français dans le domaine de l'imagerie médicale, un Spécialiste des Affaires Réglementaires.
Responsabilités:
- Soumettre les documents réglementaires liés aux produits pour les autorités mondiales, hors Europe (US, APAC, Middle East and Africa), particulièrement les États-Unis (FDA, dépôt 510(k)).
- Maintenir les dossiers réglementaires internationaux et répondre aux questions des agences réglementaires pour assurer la conformité et la certification des produits.
- Assurer la conformité des produits avec les exigences de la FDA et d'autres autorités réglementaires (organismes notifiés, autorités juridiques internationales, conseillers juridiques et autres consultants)
- Participer à la conformité du système de gestion de la qualité et de l'environnement de l'entreprise avec les exigences réglementaires internes ou externes.
- Fournir des contributions aux équipes de projet pour intégrer les exigences de la FDA et d'autres autorités réglementaires dans le processus de développement de produit.
- Surveiller les évolutions normatives et réglementaires et évaluer leur impact.
Compétences Requises:
- 2-5 ans d'expérience en affaires réglementaires dans l'industrie des dispositifs médicaux
- Expérience FDA et dépôt 510(k)
- Excellentes capacités de communication en français et anglais.
- Rigoureux, force de proposition, avec de bonnes compétences organisationnelles.
Si vous aspirez à jouer un rôle clé dans le développement international d'une entreprise dynamique, en vous engageant dans une variété de projets prometteurs, cette offre est faite pour vous
Type d'emploi : Temps plein, CDI
Salaire : 45 000,00€ à 55 000,00€ par an
Programmation:
- Travail en journée
Lieu du poste : En présentiel
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