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Regulatory Affairs_Medical Device

3 mesi fa

Milano, Lombardia, Italia Adecco Italia A tempo pieno
Adecco LifeScience, divisione specializzata del gruppo Adecco, ricerca per una realtà che produce e distribuisce dispositivi medici in ambito ortopedico un/una:

Regulatory Affairs_ Medical Device

In collaborazione con il team attuale, sia regolatorio che qualità, le attività che la risorsa dovrà svolgere
sono le seguenti:

• Redazione, mantenimento ed aggiornamento della documentazione tecnica in riferimento alle
regolamentazioni del settore, i.e. Direttiva 93/42/CEE e MDR 2017/745;

• Preparazione documentazione varia per la registrazione dei dispositivi presso enti stranieri; -
Redazione di relazioni tecniche, report clinici, registrazioni sul database del Ministero della Salute
etc.;

• Applicazione delle norme tecniche di settore ai dispositivi medici di riferimento, i.e. Protesica
(protesi d'anca e protesi di ginocchio) e Osteosintesi e relativo strumentario chirurgico;

• Gestione e mantenimento del sistema di gestione qualità aziendale in accordo agli standard ISO
9001 e ISO 1345

La risorsa ideale è in possesso dei seguenti requisiti:

• Titolo di studi: Laurea in discipline tecnico–scientifiche (Ingegneria, CTF) o umanistiche
(Giurisprudenza); costituisce requisito preferenziale il conseguimento di un Master in Regulatory
Affairs;

• Esperienze professionali e tecniche: precedente esperienza nel ruolo nell'ambito di società del
settore Medical Device - Pharma di carattere internazionale e contraddistinte da un'organizzazione
produttiva volta alla produzione di prodotti finiti;

• Competenze informatiche: utilizzo evoluto del pacchetto MS Office (in particolare Word, Excel);

• Competenze linguistiche: buona conoscenza dell'inglese (minimo B2) tecnico/scientifico scritto.

Sede: Milano

Si offre contratto alle dirette dipendenze dell'azienda.

I candidati interessati possono inviare la propria candidatura via mail, allegando il CV in formato Word, corredato di autorizzazione al trattamento dei dati personali all'indirizzo e-mail: I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy (Regolamento UE n. 2016/679).

Data inizio prevista: 26/06/2024

Categoria Professionale: Scientifico / Farmaceutico

Città: Milano (Milano)

Patenti:
  • B
Disponibilità oraria:
  • Totale disponibilità
I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679).

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