Quality and Regulatory Affairs Specialist

1 settimana fa


Francavilla al Mare, Abruzzo, Italia H2H ADVISORY BENEFIT CORPORATION A tempo pieno
Quality & Regulatory Affairs

Il Gruppo Gada è leader in Italia nella distribuzione di dispositivi medici e nell'erogazione di servizi sanitari integrati.

Descrizione del ruolo

Siamo alla ricerca di un Quality & Regulatory Affairs da inserire nell'organizzazione presso la sede di Francavilla al Mare/Roma.

Attività principali
  • Gestione della Documentazione Tecnica dei dispositivi commercializzati (Schede Tecniche; DoC; Certificati CE; IFU, Label; ISO etc);
  • Gestione Quality Agreement con i fornitori e clienti;
  • Gestione Anagrafica Articoli (ERP: SAP B1);
  • Post Market Surveillance: Presa in carico, gestione e archiviazione di reclami, recall, Field Safety Notice ed Fied Safety Corrective Action dei dispositivi commercializzati;
  • Studio della normativa vigente in materia di Dispositivi Medici e della sua evoluzione.
Requisiti
  • Preferibile Laurea in Ingegneria Biomedica oppure in Economia/Giurisprudenza;
  • Esperienza di 1 anno in ruolo analogo;
  • Conoscenza di base dei processi di gestione della Documentazione di prodotto e degli affari regolatori;
  • Sede di lavoro: Francavilla al Mare o Roma;
  • Conoscenza del Pacchetto Office e buona conoscenza di Excel;
  • Ottima conoscenza della Lingua inglese.
Offerte

Formazione accurata e dedicata, che permetta alla risorsa di accrescere le sue competenze e abilità, ed allo stesso tempo di entrare nelle dinamiche e nei ritmi aziendali.

Contratto diretto con l'azienda e Total compensation commisurata al livello d'esperienza maturata nel ruolo.



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