Regulatory And Post Market Surveillance Engineer

3 mesi fa


San Daniele del Friuli, Italia Limacorporate A tempo pieno

Stiamo cercando un Ingegnere Biomedico, o dei Materiali, o Meccanico per la nostra sede di San Daniele del Friuli (UD) per una posizione nel Dipartimento regolamentario e di sorveglianza post commercializzazione. La risorsa si occuperà di preparare la documentazione tecnica necessaria per la registrazione, il mantenimento e lo sviluppo di nuovi dispositivi medicali sul mercato europeo ed estero.

Si occuperà inoltre di fornire assistenza nelle attività di post-commercializzazione (gestione incidenti, eventi avversi, ritiri prodotto dal mercato).

Principali responsabilità: Gestire la raccolta, la preparazione, l'invio e l'aggiornamento della documentazione tecnica per la registrazione dei prodotti nei vari mercati, per l'investigazione di incidenti, per il ritiro di prodotti dal mercato. Gestire i rapporti con le funzioni aziendali per fornire loro le informazioni e i documenti necessari per la redazione della documentazione tecnica di prodotto. Mantenere i rapporti con le autorità sanitarie competenti e gli enti notificati, rispondendo prontamente a eventuali richieste. Istruzione & esperienza: Laurea ad indirizzo tecnico/scientifico. Una precedente esperienza, anche breve, nelle attività previste dal ruolo è preferibile. Altre skills: Ottima conoscenza della lingua inglese (scritta e parlata). Precisione e metodo. Buona gestione del tempo e delle priorità. Ottime capacità relazionali in contesti multiculturali. Predisposizione all'apprendimento e al lavoro di squadra. Ottima conoscenza del pacchetto Office, in particolare di Excel.

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