Regulatory Affairs Specialist

2 settimane fa


Milan, Italia Antal International Network A tempo pieno

Il/la candidato/a farà parte della 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 2 anni;
  • 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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