Person Responsible For Regulatory Compliance
3 giorni fa
Adecco Italia spa ricerca per azienda cliente nel settore elettromedicale una figura professionale da inserire nel ruolo di PRRC (Person Responsible for Regulatory Compliance) Questa figura professionale e' richiesta dal Regolamento UE 2017/745 (MDR) sui dispositivi medici e dal Regolamento UE 2017/746 (IVDR) sui dispositivi medico-diagnostici in vitro ed ha il compito di garantire la conformita regolatoria dei dispositivi medici fabbricati e immessi sul mercato dall'azienda.
Il PRRC deve possedere competenze comprovate in campo regolatorio e un'adeguata esperienza nel settore dei dispositivi medici.
Di seguito i requisiti necessari: - Diploma di Laurea in Giurisprudenza, Medicina, Farmacia, Ingegneria o altre discipline scientifiche.
- Almeno un anno di esperienza in attivita regolatorie o di gestione della qualita nel settore dei dispositivi medici (o dispositivi medico-diagnostici in vitro per l'IVDR).
Oppure, se non si possiede un titolo di studio specifico, e' richiesta un'esperienza di almeno quattro anni in ruoli regolatori o di gestione della qualita nel settore.
Il candidato inserito dovra assumere la responsabilita della supervisione e controllo della fabbricazione dei dispositivi in termini di: - conformita al sistema di gestione della qualita - redazione e aggiornamento della documentazione tecnica e della dichiarazione di conformita UE - attivita di sorveglianza e vigilanza post commercializzazione, in modo che siano soddisfatti gli obblighi Si offre contratto a tempo determinato, full time, della durata di 6 mesi rinnovabile.
Ral da definire.
Zona di lavoro Roma Flaminio.
Esperienze lavorative: Regulatory affairs specialist - 12 mesi Titolo di studio: Laurea Magistrale Disponibilita oraria: Full Time Patente: B
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