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Chargé(e) PMS - Dispositifs Médicaux

Business Type: Medical Devices Company
Job Type: Medical Devices
Job Level: Experienced (non manager)
Position: Full Time
Location: France
Reference: MT - 61935 -
Closing Date: 21/08/19
Job Details:

Au sein du service Qualité Affaires Réglementaires, vous participez aux missions principales suivantes :

- Gestion de la PMS et rédaction des rapports (PMS plan, PMS report, PSUR report)

- Enregistrement et analyse des PER (signalements terrains provenant de tous les marchés de commercialisation)

- Gestion des réclamations
o Enregistrement, analyse et préparation de la clôture
o Investigations, recherche des causes, rédaction de la réponse aux clients
o Suivi des CAPA associées

- Gestion des déclarations réglementaires de matériovigilance auprès des autorités compétentes incluant les rappels de lot ou actions de sécurité

- Enregistrement et analyse des incidents des produits similaires

- Collecte et saisie des données dans les bases européennes et mondiales et dans les registres

- Analyse des registres sur les produits similaires

- Analyse et synthèse bibliographique des produits similaires

NonStop Recruitment Posted by:: NonStop Recruitment (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 14/08/2019 | NPJ Ref: 240257
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