Regulatory Affairs

2 settimane fa

Monza, Italia S&You A tempo pieno

Il nostro cliente è una start up innovativa operante nel settore dei dispositivi medici.
Realtà fondata da personalità di spicco nel mondo della ricerca scientifica in ambito medico-chirurgico, da qualche anno ha intrapreso un percorso di strutturazione e crescita.
Per potenziamento del team R&D attualmente impegnato nello sviluppo di dispositivi medici attivi ad alto contenuto tecnologico, stiamo selezionando una figura di: REGULATORY AFFAIRS SENIOR SPECIALIST La risorsa, che risponderà alla Direzione e opererà col supporto di consulenti esterni, gestirà le attività regolatorie finalizzate all'ottenimento della marcatura CE e della certificazione FDA.
Nel dettaglio si occuperà di: Redazione, revisione, aggiornamento e raccolta della documentazione componente il Design History File, in accordo all'MDR 2017/745 e allo standard FDA; Gestione rapporti con Organismo Notificato.
; Coordinamento consulenti esterni che supportano l'azienda in materia di Validazione (validazione pre-clinica, validazione clinica, usabilità) Desideriamo entrare in contatto con candidat? con esperienza pluriennale nel ruolo maturata nel settore medical devices, solida conoscenza delle norme MDR 2017/745 e FDA, dimestichezza con gli standard di riferimento (ISO 134585, IEC/UL/CSA, ecc.).
Avranno canale preferenziale andidat? con certificazione PRRC ed esperienza nei percorsi di certificazione di dispositivi medici di classe IIA e IIB.
Si offre: assunzione diretta a tempo indeterminato.
Luogo di lavoro: richiesta la disponibilità ad iniziale periodo di lavoro 100% in presenza, presso sede in provincia di Monza (MB).
Possibilità di smart working parziale dopo i primi 6-12 mesi L'offerta è rivolta a candidat? nel rispetto del Dlgs 198/2006 e dei Dlgs 215/2003 e 216/2003.
Le persone interessate sono invitate a leggere l' informativa privacy ex artt.
13 e 14 del Reg.
UE 2016/679.
Aut.
Min.
Prot.
N. 1207 – SG del 16/12/2004

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