Clinical Evaluation and Post Market Surveillance specialist- Imola

3 settimane fa

Bologna, Emilia-Romagna, Italia Jobbydoo A tempo pieno

Breve Clinical Evaluation and Post MarketSurveillance Specialist - Imola (BO) In Capgemini Engineering,leader mondiale nei servizi di ingegneria, uniamo un team globaledi ingegner*, scienziat* e architett* per aiutare le aziende piùinnovative del mondo a liberare il loro potenziale. Dai veicoliautonomi ai robot salvavita, i nostri talenti in tecnologiadigitale e software pensano fuori dagli schemi offrendo serviziunici di R&D e ingegneria in tutti i settori. Come ClinicalEvaluation and Post Market Surveillance specialist presso CapgeminiEngineering parteciperai a progetti afferenti al settore MedicalDevice e lavorerai nell'ambito della nostra practice ComplianceQuality and Regulatory. In questo ruolo ti occuperai delle seguentiattività: - Valutazione clinica di dispositivi medici con attivitàdi pianificazione e monitoraggio continuo della sicurezza e delleprestazioni dei prodotti, redazione di report per assicurare ilmantenimento del marchio CE in conformità alle normative vigenti; -Gestione della documentazione clinica: creazione, mantenimento eaggiornamento di documenti clinici (Post Market Suirvellance Plan,Periodic Safety Update Report) per il monitoraggio dei dispositivimedici in seguito a commercializzazione (attività di Post MarketSurveillance) - Redazione di capitolati tecnici. - Coordinamentodei centri per la raccolta di evidenze cliniche e gestione diattività per la validazione clinica dei prodotti. Titoli di studioYOUR PROFILE: Sei la risorsa che stiamo cercando se possiedi: -Approfondita conoscenza del Medical Device Regulation (RegolamentoUE 2017/745) e delle normative correlate - Esperienzanell'applicazione di MEDDEV 2.7/1 Rev. 4, ISO 13485 e delle lineeguida per la sorveglianza post- market di dispositivi medici -Ottima conoscenza della lingua inglese, sia scritta che parlata -Capacità di redigere documentazione tecnica e dettagliata Nota Larisorsa ideale è in possesso di laurea specialistica in MaterieScientifiche (CTF, Farmacia, Biologia, Biotecnologie, Ingegneria) eha maturato almeno 2-3 anni di esperienza professionale,preferibilmente in ruoli legati agli affari clinici. WHAT YOU'LLLOVE ABOUT WORKING HERE - Riconosciamo l'importanza della modalitàdi lavoro flessibile per fornire un supporto concreto ai nostridipendenti: che si tratti di lavoro da remoto o di orari di lavoroflessibili, avrai un ambiente per mantenere un sano equilibrio travita lavorativa e vita privata; - Al centro della nostra missionec'è la crescita della tua carriera. I nostri programmi di crescitaprofessionale sono pensati per supportarti nell'esplorare un mondodi opportunità; - Ci impegniamo a favorire lo sviluppo delpotenziale delle nostre risorse, coinvolgendole in prima personanella vita aziendale per motivarle a migliorare le loroperformance, grazie anche alla possibilità di seguire percorsiformativi ad hoc e ottenere certificazioni sulle ultime tecnologie;- Siamo impegnati a migliorare le nostre prestazioni collettivegrazie al nostro ambiente di lavoro inclusivo in cui talentidiversi trovano adeguata valorizzazione. La diversity costituisceun aspetto essenziale della nostra cultura aziendale, espandendo inostri orizzonti attraverso le dinamiche legate ad esperienza,cultura, etnia, regole di comportamento aziendali, personalità ecomunicazione. Responsabilità lavorative Location: Imola (BO)Tipologia contrattuale: Contratto a tempo Indeterminato. Laretribuzione verrà concordata in sede di colloquio. ABOUT CAPGEMINIGROUP Capgemini Engineering può contare su più di 55.000 membri diun team di ingegner*, scienziat* in oltre 30 paesi nel mondo, concompetenze in diversi settori che includono Aeronautics, Space,Defense, Naval, Automotive, Rail, Infrastructure &Transportation, Energy, Utilities & Chemicals, Life Sciences,Communications, Semiconductor & Electronics, Industrial &Consumer, Software & Internet. Capgemini Engineering è parteintegrante del Gruppo Capgemini, partner globale per latrasformazione tecnologica e di business delle aziende, supporta isuoi clienti nella loro transizione verso un mondo più digitale esostenibile, creando impatto positivo per le imprese e la società.Capgemini è un gruppo responsabile e diversificato di 340.000persone presente in più di 50 paesi nel mondo. Oltre 55 anni diesperienza rendono Capgemini un partner affidabile per i suoiclienti, in grado di fornire soluzioni innovative per le loroesigenze di business. Capgemini offre servizi e soluzioniend-to-end, dalla strategia e progettazione all'ingegneria, graziealle sue competenze all'avanguardia in ambito AI, cloud e dati,alla sua esperienza settoriale e al suo ecosistema di partner. Nel2023 il Gruppo ha registrato ricavi complessivi pari a 22,5miliardi di euro. Get the Future You Want | www.capgemini.com Applynow L'offerta di lavoro si intende rivolta all'uno e all'altrosesso in ottemperanza al D.Lgs. 198/2006. Inoltre, prestiamoattenzione e sensibilità alle future risorse appartenenti allecategorie protette, ai sensi degli articoli 1 e 18 della legge 68del '99. I dati personali saranno trattati in conformità alledisposizioni contenute nel regolamento UE 2016/679.

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