Quality & Regulatory Manager
4 settimane fa
Categoria: Healthcare / Pharmaceutical Luogo di lavoro: Milano e provincia Il nostro cliente è una nota realtà italiana che si impegna ad identificare e sviluppare soluzioni scientificamente fondate, pensate per rispondere ai bisogni di pazienti e medici in numerose aree terapeutiche e indicazioni cliniche. Per sostenere la crescita del nostro cliente e garantire i più elevati standard di compliance, siamo alla ricerca di un/una Quality & Regulatory Manager senior, con solida esperienza nel ruolo. Definire e implementare la strategia regolatoria con focus sui medical device di sostanza, assicurando l'allineamento con gli obiettivi aziendali e i requisiti normativi internazionali. Garantire la piena conformità alle normative europee (MDR 2017/745) e agli standard di qualità applicabili. Gestire e supervisionare i rapporti con organismi notificati, autorità competenti e partner internazionali. Valutare l'impatto strategico delle registrazioni regolatorie sui mercati target e fornire raccomandazioni al top management. Coordinare le attività di Quality Assurance, incluse gestione del QMS, audit interni ed esterni, CAPA, gestione reclami e post-market surveillance. Sviluppare e mantenere procedure interne, assicurando un approccio proattivo e risk-based. Supportare la Direzione nella definizione di piani di sviluppo e nell'analisi di opportunità di business legate a nuovi mercati/prodotti. Guidare e motivare il team Quality & Regulatory, promuovendo una cultura orientata alla qualità e al miglioramento continuo. Requisiti Laurea in discipline scientifiche (Farmacia, Chimica, Biologia, Ingegneria Biomedica o equivalenti). Esperienza consolidata (minimo 8-10 anni) in ambito Quality & Regulatory nel settore dei medical device, con focus su dispositivi di sostanza. Conoscenza approfondita del Regolamento MDR 2017/745 e delle normative internazionali di riferimento. Forte capacità di leadership, visione strategica e attitudine al problem solving. Esperienza nel supportare decisioni di business legate a tematiche regolatorie. Ottima conoscenza della lingua inglese (scritta e parlata); la conoscenza di altre lingue è un plus. Eccellenti doti comunicative, capacità di influenzare stakeholder interni ed esterni e di operare in contesti internazionali. #J-18808-Ljbffr
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