Regulatory Affairs Specialist Senior Medical Devices
3 giorni fa
Farmapiù Bologna, divisione specialistica del gruppo Lavoropiù, cerca un/a Regulatory Affairs Specialist Senior con almeno 5/6 anni di esperienza nel ruolo e nel settore dispositivi medici per azienda cliente, produttore biomedicale, sita a Medolla (MO).La risorsa si occuperà di Gestire le attività di registrazione in ambito UE, FDA e altri paesi extra- UE.Requisiti:Laurea in discipline scientifiche o equipollenti;Esperienza in redazione Fascicoli Tecnici, Documentazione TecnicaConoscenza approfondita di Regolamento (UE) ********, Direttiva *****/CEE e ISO *****Conoscenza attività di Risk Management, PMS e PMCF, Clinical EvaluationOttima conoscenza della lingua inglese5/6 anni di esperienza nel ruolo ed in aziende manifatturiere del settore DMsProattività e buone capacità relazionali e di lavoro in team.Attività:Redazione e aggiornamento di Documentazione Tecnica MDR – Regolamento (UE) ********;Aggiornamento di Documentazione Tecnica MDD – Direttiva *****/CEE e successivi aggiornamenti;Preparazione documentazione per registrazioni FDA;Preparazione documentazione varia per registrazioni in paesi extra-UE;Supporto alle altre aree aziendali: Risk Management, Post Market Surveillance, Clinical Evalution, Vigilance, ecc.Supporto nella verifica di labeling, IFU e altri documenti;Verifica norme e leggi applicabili e aggiornamento del relativo elenco;Attività di registrazione in database EUDAMED, FDA, Ministero della Salute e altre Autorità Competenti.Si offre:Inserimento con contratto a tempo indeterminato.CCNL Metalmeccanica - Industria - Range ral di ingresso: *****K1 gg di sw a settimanaBuoni pasto giornalieriLivello e RAL da commisurarsi sulla base dell'esperienza.Luogo di lavoro: Medolla (MO)
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Regulatory Affairs Specialist
2 settimane fa
Lazio, Italia Altro A tempo pienoRegulatory Affairs Specialist -Medical DevicesJoin to apply for theRegulatory Affairs Specialist -Medical Devicesrole atNordberg MedicalRegulatory Affairs Specialist -Medical DevicesJoin to apply for theRegulatory Affairs Specialist -Medical Devicesrole atNordberg MedicalGet AI-powered advice on this job and more exclusive features.TheRegulatory Affairs...
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Lazio, Italia Biopharmed A tempo pienoBiopharmed è la boutique di head hunting progettata per la ricerca e selezione di profili tecnici e specialistici del mondo Life Sciences & Chemical.PosizioneRicerchiamo una figura da inserire nel team Regulatory Affairs for Medical Devices per importante azienda operante nel settore farmaceutico e del medical device.Principali ResponsabilitàCoordinamento...
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Lazio, Italia Vantive Manufacturing A tempo pienoA leading medical device firm in Italy is seeking a Regulatory Affairs professional to support CE marking activities for medical devices.The role involves ensuring regulatory compliance, developing strategies, and collaborating with cross-functional teams.Ideal candidates will have 3-5 years of experience in Regulatory Affairs and possess a good...
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Lazio, Italia Resmed Inc A tempo pienoA global healthcare technology firm in Italy is looking for an Advanced Regulatory Affairs Specialist to join their team.You will participate in all regulatory activities related to the import and distribution of medical devices within the EMEA region, ensuring compliance with regulations.The role requires a Bachelor's degree and experience in the medical...
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Regulatory Affairs Associate – Medical Devices
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Lazio, Italia Resourcing Life Science A tempo pienoA life sciences recruitment firm is seeking a Regulatory Affairs professional with at least 4 years of experience in the medical device sector.The role involves conducting regulatory assessments, managing registrations, and supporting FDA submissions.Excellent communication and problem-solving skills are essential, along with fluency in English.If you are...
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