Regulatory Affairs Specialist Senior Medical Devices

3 giorni fa


Lazio, Italia Lavoropiu Spa A tempo pieno

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)



  • Lazio, Italia Altro A tempo pieno

    Regulatory 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...


  • Lazio, Italia Biopharmed A tempo pieno

    Biopharmed 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...


  • Lazio, Italia Vantive Manufacturing A tempo pieno

    A 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...


  • Lazio, Italia Resmed Inc A tempo pieno

    A 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...


  • Lazio, Italia Resourcing Life Science A tempo pieno

    A 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...


  • Lazio, Italia Herbalife International, Inc. A tempo pieno

    Sr Specialist, Global Regulatory Affairs Herbalife Italy – RomeVia Amsterdam, 125Roma*****About the roleWe're looking for an experienced Senior Specialist, Global Regulatory Affairs to join our dynamic Global Regulatory Affairs team, supporting the Europe & Africa (E&A) sub-region.This role is based in Rome, Italy and plays a key part in ensuring the...


  • Lazio, Italia Vantive Manufacturing A tempo pieno

    Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere.For 70 years our team has driven meaningful innovations in kidney care.As we build on our legacy we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while...


  • Lazio, Italia Buscojobs IT C2 A tempo pieno

    The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...


  • Lazio, Italia Altro A tempo pieno

    A premier certification body is seeking a home-based Technical Specialist & Scheme Manager to evaluate medical devices for compliance and support manufacturers throughout their certification life cycle.The position requires at least 5 years of experience with active medical devices, a relevant degree, and a deep understanding of regulatory requirements.This...


  • Lazio, Italia Jobtome A tempo pieno

    3 days ago Be among the first 25 applicantsSerioplast, a global leader in rigid plastic packaging, is looking for a Senior Regulatory Affairs Specialist to join our Quality team at our Global Headquarters in Seriate (BG).This is an exciting opportunity to be part of an international, dynamic, and results-driven environment where quality and continuous...