Lavori attuali relativi a Medical Device Regulatory Affairs Specialist - Milano - Ganassini Corporate

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Medical Device Regulatory Affairs Specialist

2 mesi fa

Milano, Italia Ganassini Corporate A tempo pieno

Il gruppo Ganassini cerca un/a Medical Device Regulatory Affairs Specialist .
La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione Tecnica in tutte le attività regolatorie sui dispositivi medici a base di sostanze.
Dovrà essere in grado di gestire autonomamente la preparazione dei fascicoli tecnici dei prodotti.
Obiettivi principali e responsabilità: Redigere e aggiornare i fascicoli tecnici in relazione alla legislazione e alle linee guida internazionali per i paesi in cui l'azienda esporta i propri prodotti.
Assicurare il processo del ciclo di vita del prodotto in conformità con il dossier registrato e monitorare qualsiasi impegno/richiesta ricevuta dalle autorità.
Preparare e notificare le variazioni alle autorità/enti preposti in base alle normative e ai requisiti nazionali.
Gestire e risolvere i rilievi sui Fascicoli Tecnici.
Revisione e controllo dei documenti quali BEP/BER, CEP/CER, PMCF Plan e Report.
Gestire rapporti con terzi per eventuali controlli che non possono essere svolti internamente (cliniche, analisi chimico fisiche, microbiologiche, biocompatibilità, altre).
Controllo artworks.
Notifica dei prodotti nella banca dati ministeriale e EUDAMED.
Requisiti di base: Laurea in discipline scientifiche (Biologia, Chimica, CTF, Farmacia, etc.).
Avere un'esperienza pregressa di almeno 2 anni in ruolo analogo.
Ottima conoscenza delle normative nazionali ed europea nel settore Medical Device con particolare riferimento a quelli a base di sostanze.
Eventuale conoscenza aggiuntiva della gestione regolatoria di prodotti cosmetici ed integratori alimentari costituirà requisito preferenziale.
Sede di lavoro: Milano (Porto di Mare).
L'inquadramento e la retribuzione saranno in linea con l'esperienza e la seniority del candidato/a scelto.
Il presente annuncio è rivolto ad entrambi i sessi, ai sensi delle leggi 903/77 e 125/91 e a persone di tutte le età e tutte le nazionalità, ai sensi dei decreti legislativi 215/03 e 216/03.
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