Coordinator Regulatory Affairs For Medical Devices | Sanremo

17 ore fa

Lazio, Italia Biopharmed A tempo pieno

Biopharmed è la boutique di head hunting progettata per la ricerca e selezione di profili tecnici e specialistici del mondo Life Sciences & Chemical.PosizioneRicerchiamo una figura da inserire nel team Regulatory Affairs for Medical Devices per importante azienda operante nel settore farmaceutico e del medical device.Principali ResponsabilitàCoordinamento del team Regulatory Affairs per dispositivi medici.Preparazione, gestione e aggiornamento di fascicoli tecnici per dispositivi medici a base di sostanze, secondo il Regolamento (UE) ******** (MDR).Gestione della documentazione tecnica da includere nei fascicoli per garantire la conformità alle normative europee e internazionali.Applicazione del Regolamento ******** (UE) nei processi di certificazione dei dispositivi medici, con particolare attenzione ai dispositivi a base di sostanze.Coordinamento e gestione delle relazioni con i distributori esterni per finalizzare le registrazioni, garantendo la corretta applicazione delle normative specifiche.Collaborazione con i team di sviluppo prodotto e qualità per garantire che la documentazione tecnica sia completa e conforme alle normative in vigore.Monitoraggio e aggiornamento continuo delle normative in vigore sui mercati esteri principali, tra cui Russia, Cina e Brasile.Job RequirementsRequisiti essenzialiEsperienza pregressa nel campo della regolamentazione o dei sistemi di gestione della qualità relativi ai dispositivi medici a base di sostanze, con conoscenza approfondita del Regolamento ******** (UE).Laurea in giurisprudenza, medicina, farmacia, ingegneria o altra disciplina scientifica pertinente.Conoscenza e gestione della documentazione tecnica necessaria per la certificazione e registrazione dei dispositivi medici.Creazione di dossier in maniera autonoma in base ai nuovi requisiti MDROttima conoscenza della lingua inglese, sia scritta che parlata.Requisiti SecondariGradita esperienza registrativa sui mercati esteri di Russia, Cina, Brasile.Gradita esperienza pregressa nel coordinamento di team.Other InfoSede di lavoro: Sanremo / Milano.#J-*****-Ljbffr

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