Regulatory Affairs Specialist
4 settimane fa
Per azienda cliente, realtà leader nel settore farmaceutico e cosmetico in Italia, siamo alla ricerca di una figura di Regulatory Affairs Specialist - Medical Devices.
Redigere e aggiornare la documentazione relativa alla legislazione e alle linee guida degli enti regolatori nazionali ed internazionali con cui ci si interfaccia; Assicurare la conformità del prodotto e monitorare qualsiasi impegno/richiesta ricevuta dalle autorità; Preparare e notificare qualsiasi modifica o variazione di prodotto alle autorità/enti preposti in base alle normative e ai requisiti nazionali; Gestione e risoluzione dei rilievi sui Fascicoli Tecnici; Revisione e controllo dei documenti quali Clinical Evaluation Plans e Clinical Evaluation Reports; Gestire rapporti con terzi per eventuali controlli necessari; Controllo artworks; Notifica dei prodotti nella banca dati del Ministero e Eudamed.
Laurea in discipline scientifiche; Esperienza pregressa di almeno 2 anni in ruolo analogo; Ottima conoscenza delle normative nazionali ed europea nel settore Medical Device; Conoscenza della gestione regolatoria di prodotti cosmetici ed integratori alimentari (preferibile).
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