Head of Regulatory Affairs

1 mese fa


Genova, Italia Hunters Group A tempo pieno

Per il nostro cliente, azienda affermata nel mondo Medical Devices, siamo alla ricerca di una figura di Head of Regulatory Affairs.
- Principali responsabilità- Gestire le operazioni quotidiane del reparto RA in modo coerente con la pianificazione strategica impartita dal Direttore RA QA e con gli obiettivi dell'azienda;
- Assicurare la pianificazione e l'esecuzione delle richieste di autorizzazione per i dispositivi medici dell'azienda nell'UE, negli Stati Uniti e in tutti i principali paesi/mercati esteri;
- Fungere da esperto delle varie normative e coordinare la risoluzione dei problemi normativi attraverso l'uso di risorse interne o di consulenti esterni, se necessario;
- Comunicare i requisiti di approvazione normativa e garantire l'impegno del reparto per l'orientamento normativo e il supporto alla R&D durante l'intero ciclo di vita del prodotto;
- Assicurare l'aggiornamento periodico dei fascicoli tecnici dell'azienda;
- Assistere il Direttore RA QA nel fornire un supporto normativo strategico per lo sviluppo del business;
- Condurre corsi di formazione e/o fornire materiali appropriati, se necessario, al fine di migliorare la conoscenza interna del lavoro in un ambiente regolamentato;
- Partecipare a riunioni di lavoro con clienti e partner esterni;
- Gestire e coordinare un team di risorse.
- Principali caratteristiche richieste- Laurea in Biologia, Chimica, Bioingegneria o scienze affini;
- 10+ anni di esperienza nel settore dei dispositivi medici in un ruolo di RA, con almeno 3+ anni come manager in un'azienda di dispositivi medici che opera nei mercati internazionali;
- Conoscenza approfondita di MDR (EU) 2017/745 e delle normative FDA;
- Conoscenza degli standard ISO 13485:2016;
- Esperienza nella gestione delle interazioni con gli organismi notificati e con le autorità sanitarie di regolamentazione;
- Conoscenza fluente dell'inglese;
- Forti doti di leadership e comunicative;
- Spiccate capacità organizzative, di pianificazione e di follow-up;
- Atteggiamento positivo;
- Orientamento al raggiungimento degli obiettivi;
- Capacità di agire in maniera proattiva, in grado di fornire risultati efficaci sia direttamente che attraverso il proprio team.
- Il presente annuncio è rivolto ad entrambi i sessi, ai sensi delle leggi 903/77 e 125/91, e a persone di tutte le età e tutte le nazionalità, ai sensi dei decreti legislativi 215/03 e 216/03._



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