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Regulatory Affairs Specialist
2 mesi fa
HiRevo LifeScience è la specializzazione di Gi Group, prima multinazionale del lavoro italiana, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Farmaceutico e Medicale.
L'azienda cliente nasce nel 2009 nel vercellese ed è la prima azienda italiana a produrre dispositivi salvavita. I dispositivi medici sono impiegati nell'area cardiovascolare e interventistica. Ricerchiamo: junior Regulatory Affairs Specialist All'interno del Dipartimento Global Sales & Regulatory Affair e in collaborazione con il Dipartimento Quality Assurance, dopo un periodo di training, ti occuperai di:
Coordinare e provvedere alle registrazioni e all'ottenimento delle approvazioni per la commercializzazione (nuove, aggiornamenti, rinnovi, modifiche) dei prodotti in portfolio.Contattare i distributori e/o consulenti dei paesi di riferimento per collaborare attivamente alla preparazione della documentazione necessaria, richiesta anche dalle autorità competenti, per la richiesta di approvazione/registrazione.Revisionare etichette e confezionamento facendo riferimento alle normative più aggiornate. Interagire con i dipartimenti aziendali per la raccolta delle informazioni necessarie alle registrazioni e supportarli nella definizione dei requisiti della stessa elaborando anche documentazione specifica (sulla base delle informazioni disponibili) che soddisfi le richieste delle autorità coinvolte. Assicurare la corretta gestione della documentazione trasmessa alle autorità (invio, ricezione e archiviazione). In particolare, mantenere aggiornato l'archivio delle registrazioni extra –cee Assicurare la corretta pianificazione ed esecuzione dei controlli alle spedizioni dei prodotti (APDL).Requisiti richiesti:laurea scientifica, Master in affari regolatori, esperienza di internship in azienda medicale.
L'azienda offre un contratto a tempo indeterminato, CCNL Chimico Farmaceutico. Livello C2. Welfare. Mensa aziendale. Servizio navetta da Torino.
Sede di lavoro: Saluggia (VC).
Orario di lavoro: da lunedì a venerdì in presenza, 37,75 ore, 8.15/16.45 con flessibilità di 45 minuti.
Gi Group S.p.A. è autorizzata ad operare dal Ministero del Lavoro (Aut. Min. 26/11/2004 PROT. 1101 - SG).
L'offerta si intende rivolta a candidati ambosessi, nel rispetto del D.Lgs. n. 198/2006 e ss.mm.ii. e dei Decreti Legislativi n. 215 e n. 216 del 2003 sulle parità di trattamento. I candidati sono invitati a leggere l'informativa privacy ai sensi degli artt. 13 e 14 del Reg. EU 679/2016 al seguente indirizzo www.gigroup.it/privacy-candidati
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