Regulatory Specialist and Senior Specialist

3 settimane fa

Bologna, Italia FARMA-DERMA s.r.l. A tempo pieno

FarmaDerma , azienda del Gruppo Named specializzata nello sviluppo e produzione di dispositivi medici, è alla ricerca di un/una Regulatory Affairs Specialist , in un’ottica di potenziamento del team Regolatorio.
La figura inserita si occuperà principalmente della gestione regolatoria dei dispositivi, incluse attività cliniche e pre-cliniche, insieme alla redazione e revisione della documentazione tecnica.

Valutazione della documentazione relativa ai materiali (materie prime e materiali di confezionamento);
Valutazione clinica secondo MDR e linee guida correlate;
Redazione della documentazione a supporto della sicurezza e performance dei prodotti in accordo alla normativa MDR UE;
Predisposizione, revisione e aggiornamento dei fascicoli tecnici dei dispositivi medici;
Attività di ricerca bibliografica attraverso database scientifici e supporto alla produzione della documentazione tecnico-clinica.

Laurea in Chimica e Tecnologia Farmaceutiche (CTF) , Farmacia , Biotecnologie o titoli affini;
Buona conoscenza della lingua inglese;
Preferibile esperienza in ambito regolatorio dispositivi medici in contesti strutturati;
Inserimento in un team altamente qualificato e collaborativo;
Contesto regolatorio avanzato con possibilità di crescita professionale;
Opportunità di lavorare su aspetti chiave dell’ambito RA: clinico, pre-clinico e fascicoli tecnici;
Se hai formazione scientifica e desideri crescere in un contesto sereno, collaborativo e con reali possibilità di crescita, ti invitiamo a candidarti o a condividere l’annuncio all’interno del tuo network.

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