Regulatory Affairs Specialist Italy Milan
5 mesi fa
: Quality Assurance
**Posizione: Regulatory Affairs & Clinical Specialist**
**Location: Milano provincia (on-site)**
**Retribuzione: commisurata all'effettiva esperienza**
Siamo alla ricerca di un Regulatory Affairs & Clinical Specialist per conto di un'azienda storica, basata in provincia di Milano.
Si tratta di un'azienda fabbricante di Medical Devices nel settore ortopedico, principalmente di classe III. L'azienda ha un posizionamento solido nel mercato, che l'ha portata nei suoi 30 anni di vita, ad imporsi per qualità dei prodotti anche rispetto ad aziende competitor multinazionali.
La figura ricercata andrà ad inserirsi in un già strutturato team QA/RA, occupandosi principalmente di aspetti regolatori/clinici legati al regolamento MDR. Rappresenta un'occasione di mettersi alla prova con devices ad alto rischio, in un ambiente solido e stabile.
Si richiedono:
- Laurea in ingegneria biomedica
- Esperienza nella redazione di technical files secondo regolamento MDR 2017/745
- Conoscenza normativa ISO 14155
- Capacità di gestione delle investigazioni cliniche in autonomia o tramite il supporto di CRO
- Gestione delle comunicazioni con Comitati etici
- Conoscenza del sistema di PMS ai sensi del MDR 2017/745 e della documentazione necessaria per la sua implementazione (PMS plan, PMCF plan, PMCF report, PSUR, PMS report)
- Capacità di scrittura Clinical evaluation plan (CEP) e clinical evaluation report (CER) per dispositivi medici nuovi e legacy e conoscenza MEDDEV 2.7.1. rev. 4
Troverai:
- Storica realtà nel settore medicale
- Medical devices di classe III
- Ambiente in costante crescita
- Possibilità di crescita professionale e di percorso a lungo termine
- Ambiente giovane, dinamico ed informale
- Possibilità di interazione costante con i diversi reparti aziendali: visione a 360° delle attività legate al prodotto
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