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Certification Specialist
2 mesi fa
col-wideJob Description:
Il nostro Cliente, azienda leader nel suo settore, ci ha incaricati di ricercare la figura di un/a:
CERTIFICATION SPECIALIST
La figura verrà inserita all'interno dell'Ufficio R&D della divisione Instruments e si occuperà delle attività "Regulatory" relative alla realizzazione del dossier documentale e alla certificazione dei dispositivi.
L'attività prevede l'inserimento nel team di certificazione prodotto e l'interazione con Ente Notificato.
Principali Attività e Responsabilità:
Redazione del fascicolo tecnico in conformità al Regolamento Europeo Dispositivi Medici
Raccolta e revisione della documentazione tecnica emessa dall'ufficio tecnico o dai fornitori dei componenti
Preparazione dei documenti tecnici di propria pertinenza (istruzioni, documentazione di accompagnamento…)
Assicurare la conformità regolatoria del Fascicolo Tecnico (mantenimento delle certificazioni attive e del sistema di qualità)
Assistere la redazione dei protocolli di test in conformità alle norme di prodotto (definizione format, criteri di accettabilità)
Supporto alle attività di marcatura CE e interazione con Ente Notificato
Coordinamento con i colleghi per l'esecuzione delle attività ai fini della creazione del dossier documentale
Gestire le attività di registrazione dei prodotti nei paesi extra-UE
Supporto alle attività di sviluppo firmware e software (revisione specifiche in riferimento agli aspetti normativi, definizione metodi di rilascio)
Seguire gli aggiornamenti normativi e legislativi.
Requisiti:
Diploma di Istituto Tecnico, oppure è gradita Laurea in discipline tecniche;
Preferibile esperienza maturata in aziende strutturate del settore dispositivi medici o del settore farmaceutico/meccanico;
Predisposizione alla cooperazione con i colleghi e al lavoro in team;
Buona conoscenza della lingua inglese.
Si offre contratto di assunzione diretta in azienda, livello e retribuzione saranno commisurati all'esperienza pregressa della risorsa.
Diploma di Istituto Tecnico, oppure è gradita Laurea in discipline tecniche;Preferibile esperienza maturata in aziende strutturate del settore dispositivi medici o del settore farmaceutico/meccanico;Predisposizione alla cooperazione con i colleghi e al lavoro in team;Buona conoscenza della lingua inglese.
