Regulatory Affairs Coordinator Medical Device di

18 ore fa

Milano, Italia Page Personnel Italia A tempo pieno

La persona che stiamo cercando deve aver maturato una buona esperienza in ambito Regulatory Affairs legato a Dispositivi Medici a base di sostanza, sarà responsabile della gestione e supervisione dei progetti, incluse le submission regolatorie destinate a clienti e Autorità Regolatoriesi occuperà nello specifico di:

- Supervisione e gestione del team Regulatory Affairs.
- Gestione dei processi regolatori per la registrazione di Integratori Alimentari (Direttiva 2002/46/EC, Regolamento 178/2002, Regolamento 852/2004 e Regolamento 432/2012), AFMS (Regolamento 609/2013 e Regolamento 2016/128) e Dispositivi Medici (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
- Monitoraggio quotidiano dei principali aggiornamenti normativi italiani ed europei in materia di Integratori Alimentari, Dispositivi Medici e prodotti della salute in generale.
- di cui all'art 15 MDR 2017/745

Regulatory Affairs Coordinator Medical Device di Sostanza|Azienda Farmaceutica
- Laurea in discipline scientifiche (CTF, Farmacia, Biologia, Scienze e Tecnologie Alimentari)
- Esperienza consolidata in Dipartimenti di Regulatory Affairs di aziende farmaceutiche o società di consulenza regolatorie del settore Integratori Alimentari e/o Dispositivi Medici
- Conoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di Integratori alimentari e Dispositivi Medici
- Precisione, accuratezza e cura dei dettagli
- Approccio customer-oriented
- Eccellenti capacità organizzative e rispetto delle scadenze definite
- Buone capacità comunicative
- Ottimo inglese, sia scritto che orale
- Esperienza pregressa nella gestione di un team

Il nostro cliente è una realtà farmaceutica che opera nella produzione conto terzi

Inquadramento commisurato all'effettiva seniority del professionista

Regulatory Affairs Coordinator Medical Device di Sostanza

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