Regulatory Affairs Manager

10 ore fa


Milano, Italia Antal International Network A tempo pieno

Per importante azienda cliente operante nel settore chimico-farmaceutico, siamo alla ricerca di un/una REGULATORY AFFAIRS MANAGER - MEDICAL DEVICES.
La risorsa avrà la responsabilità di gestire il team regolatorio e si occuperà di:
Gestione dei processi regolatori per la registrazione di Dispositivi Medici (MDR-Regolamento EU 2017/745 e linee guida MDCG correlate; ISO 13485; ISO 14971; ISO 14155; ISO 10993) nel rispetto dei requisiti previsti dalla normativa vigente;Supporto ai clienti per la registrazione dei prodotti in area-EU e extra-EU Revisione regolatoria dell'etichettatura e controllo grafiche;Valutazione compliance materie prime;Si richiede:
Laurea in discipline scientifiche (CTF, Farmacia, Biologia, Scienze e Tecnologie Alimentari);Esperienza di circa 5 anni;Conoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di Dispositivi Medici (MDR 2017/745)Precisione, accuratezza e cura dei dettagliCapacità organizzative e rispetto delle scadenze definite
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