Quality and Regulatory Specialist

7 giorni fa

Bologna, Italia NonStop Consulting A tempo pieno

**Contratto**:**CCNL Commercio, tempo indeterminato, full-time
**Esperienza richiesta**:**minimo 4-5 anni in ambito medicale
**Settore**:**Medicale, dispositivi medici attivi

Cerchiamo un **Quality & Regulatory Affairs Specialist** che farà parte del team Regolatorio e Qualità, coordinando attività interne ed esterne e supportando la conformità normativa e i sistemi qualità aziendali.

**Responsabilità principali**:

- Gestire e coordinare le attività di Regulatory Affairs per autorizzazioni internazionali (FDA, CE, ANVISA, Health Canada)
- Mantenere il sistema qualità secondo **ISO 13485, MDSAP e normative correlate**
- Collaborare con i reparti interni per garantire la conformità dei processi produttivi e documentali
- Aggiornare fascicoli tecnici e documentazione di prodotto
- Supportare audit interni ed esterni, ispezioni degli enti notificati
- Coordinare consulenti e fornitori per attività regolatorie
- Monitorare l'evoluzione normativa internazionale e proporre azioni correttive e preventive (CAPA)

**Requisiti**:

- Laurea in discipline scientifiche
- 4-5 anni di esperienza in ruoli analoghi nel settore medicale, preferibilmente dispositivi medici attivi
- Conoscenza normativa MDR 2017/745
- Familiarità con FDA 21 CFR Part 820, ISO 13485, MDSAP (plus)
- Ottime capacità organizzative, analitiche e di problem solving
- Inglese fluente, scritto e parlato

**Offerta**:

- Contratto a tempo indeterminato commisurata all'esperienza della persona
- Ambiente giovane e dinamico e possibilità di crescita in un contesto internazionale
- Modalità di lavoro ibrida in seguito al periodo di prova
- Percorsi di formazione continua e sviluppo professionale

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