Lavori attuali relativi a Regulatory Affair Specialist – Md - Bardi, Emilia-Romagna - S.I.I.T. S.R.L.


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Regulatory Affair Specialist – Md

3 mesi fa


Bardi, Emilia-Romagna, Italia S.I.I.T. S.R.L. A tempo pieno
Trezzano sul Naviglio (Milano) Posted 6 days ago
Il candidato/a opererà nella divisione Regulatory Affairs nel contesto produttivo di una realtà chimico-farmaceutica con ampio portafoglio prodotti/fornitori/clienti, operante su mercato internazionale, rispondendo al responsabile della funzione.
Responsabilità: Gestione dei processi regolatori per la registrazione di Dispositivi Medici (Regolamento EU 2017/745 e linee guida MDCG correlate; ISO 13485; ISO 14971; ISO 14155; ISO nel rispetto dei requisiti previsti dalla normativa vigenteSupporto ai clienti per la registrazione dei prodotti in area-EU e extra-EURevisione regolatoria dell'etichettatura e controllo graficheValutazione compliance materie primeLaurea in discipline scientifiche (CTF, Farmacia, Biologia, Scienze e Tecnologie Alimentari)Esperienza di 1/2 anni in Dipartimenti di Regulatory Affairs di aziende farmaceutiche o società di consulenza regolatorie del settore Integratori Alimentari e/o Dispositivi MediciConoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di Integratori alimentari e Dispositivi MediciPrecisione, accuratezza e cura dei dettagliCapacità organizzative e rispetto delle scadenze definite#J-18808-Ljbffr