Regulatory Affairs Specialist
3 settimane fa
Il/la candidato/a farà partedella divisione Regulatory Affairs di una nota realtà chimico-farmaceutica nostra cliente.
Responsabilità: 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; Requisiti: Laurea in discipline scientifiche (CTF, Farmacia, Biologia, Scienze e Tecnologie Alimentari) Esperienza di circa 2anni Conoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di Dispositivi Medici (MDR 2017/745) Precisione, accuratezza e cura dei dettagli Capacità organizzative e rispetto delle scadenze definite
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