Regulatory Specialist

2 settimane fa


Faenza, Italia Tema Sinergie spa A tempo pieno

Tema Sinergie, consolidata realtà in fase di forte espansione sul territorio nazionale e sui mercati esteri, specializzata nella progettazione, produzione e commercializzazione di soluzioni tecnologiche rivolte al settore farmaceutico ed ospedaliero.

**Regulatory Specialist**:
Siamo alla ricerca di una figura di Regulatory Specialist in un'ottica di sviluppo dell'organizzazione aziendale.

La risorsa verrà inserita all'interno dell'Ufficio Qualità.

Descrizione Mansioni
Raccolta ed analisi della documentazione dei prodotti distribuiti da Tema Sinergie (Dispositivi Medici)
Registrazione dei dispositivi medici (distribuiti da Tema Sinergie) sul sito internet del Ministero della Salute
Importazione e distribuzione dei dispositivi medici suddetti
Registrazioni estere per prodotti a marchio Tema Sinergie
Mantenimento dei fascicoli tecnici medicali

Requisiti
Laurea anche breve ad indirizzo tecnico preferibilmente Ingegneria Biomedicale, oppure Diploma di Istituto Tecnico
Esperienza anche mínima (es. tirocinio) in posizioni similari, preferibilmente in ambito regolatorio, di consulenza ai servizi in ambito medicale e/o certificazioni di prodotto oppure ufficio qualità
Conoscenza di nozioni relative alla normativa ISO13485 e, preferibilmente, conoscenza del Nuovo Regolamento MDR
Discreta conoscenza della lingua inglese (B2)

Si offre

Inquadramento e retribuzione commisurate alle competenze ed esperienze maturate.



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