Regulatory Affairs Specialist
2 settimane fa
MECTRON SPA, A DESIGNER AND MANUFACTURER OF DENTAL AND MEDICAL DEVICES IS LOOKING FOR Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the Senior Regulatory Affairs Manager in the registration of medical devices in EXTRA-CEE countries following a plan that is constantly updated in accordance with company strategy. Essential Duties and Responsibilities prepares, updates and reviews the documents for use in regulatory dossiers in accordance with EU MDR 745 / 2017 and international requirements. Prepares and manages technical documentations needed for submission and registrations. Interacts with project development teams in order to collect the information needed for submissions / registrations and advise them on matters that are related to regulatory processes and compliance. Registers, monitors, and maintains registrations for the company's medical devices with EXTRA-CEE countries' competent authorities as appropriate. Assist in the Compliance to the Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority and other regulatory agencies. Is also proficient in applicable standards and regulations including : ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607 and MEDDEV guidelines. Prepares and updates the Quality and Regulatory Agreements necessary for registration purposes, distribution contracts and technical assistance for the EXTRA-CEE countries concerned. Follows and promotes corporate quality procedures and standards in order to achieve and maintain adequate results. Actively participate in audit activities. Work Experience - Required Qualifications At least 3 years' experience with Regulatory Affairs in the medical device industry preferred. ISO 13485. Fluent in English. Internal Auditor Qualifications preferred. Educational Requirements Bachelor's Degree in scientific discipline. Higher-level education degree preferred. #J-18808-Ljbffr
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Regulatory Affairs Specialist
2 settimane fa
Uri (SS), Italia Whatjobs A tempo pienoMECTRON SPA, A DESIGNER AND MANUFACTURER OF DENTAL AND MEDICAL DEVICES IS LOOKING FOR Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the Senior Regulatory Affairs Manager in the registration of medical devices in EXTRA-CEE countries following a plan that is constantly updated in accordance with company strategy. Essential Duties and...
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Regulatory Affairs Specialist, Medical Devices
2 settimane fa
Uri, Italia Whatjobs A tempo pienoA medical device manufacturer is seeking a Regulatory Affairs Specialist to assist in registering medical devices in EXTRA-CEE countries. Responsibilities include preparing regulatory documents, managing submissions, and ensuring compliance with EU regulations. The ideal candidate should have a Bachelor's degree in a scientific discipline and at least 3...
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Regulatory Affairs Specialist, Medical Devices
2 settimane fa
Uri (SS), Italia Whatjobs A tempo pienoA medical device manufacturer is seeking a Regulatory Affairs Specialist to assist in registering medical devices in EXTRA-CEE countries. Responsibilities include preparing regulatory documents, managing submissions, and ensuring compliance with EU regulations. The ideal candidate should have a Bachelor's degree in a scientific discipline and at least 3...
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Regulatory Affairs
2 settimane fa
Uri, Italia Whatjobs A tempo pienoPRODECO PHARMA opera da più di 35 anni nel campo della salute proponendo un solido listino di prodotti fitoterapici (dispositivi medici ed integratori alimentari).Siamo una realtà dinamica, con una forte propensione all'innovazione e alla ricerca, presente sul territorio nazionale in quasi **** punti vendita selezionati tra farmacie, parafarmacie ed...
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Senior Regulatory Affairs Consultant
3 giorni fa
Uri, Italia Rebell Ag A tempo pienoDescrizione del posto vacanteSei pronto per entrare a far parte di unasocietà di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device?PQE Group è affermata in questo settoredal ****, garantendo una presenza internazionale grazie alle45 filialie i**** dipendentiin Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza...
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Regulatory Affairs Dispositivi Medici
2 settimane fa
Uri, Italia Whatjobs A tempo pienoUn'azienda nel settore salute cerca un Regulatory Affairs specializzato in dispositivi medici.Il candidato dovrà gestire le attività regolatorie, come la redazione della documentazione necessaria e la verifica delle normative di settore.È necessaria una laurea in discipline scientifiche e almeno 2 anni di esperienza nel settore.Richieste ottime doti...
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Senior Regulatory Affairs Lead
3 giorni fa
Uri, Italia Rebell Ag A tempo pienoUna società di consulenza farmaceutica cerca un Senior Regulatory Affairs con 5-7 anni di esperienza in ambito Regulatory Affairs.La persona selezionata coordinerà attività regolatorie e supporterà lo sviluppo dei progetti, garantendo conformità con le normative.Si richiede laurea in disciplina scientifica e ottima conoscenza dell'inglese.L'offerta...
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Uri, Italia Cpl Taylor By Synergos Srl - Ricerca E Selezione Personale Qualificato A tempo pienoSENIOR REGULATORY CONSULTANT – LIFE SCIENCES (Ref. ANN******)Reparto:Life Sciences – Consulenza e soluzioni digitali per il settore Life Sciences, sede in Italia.Località:Sedi principali: Roma, Verona, Milano.Si valutano profili provenienti da queste città.Contratto:Tempo indeterminato, full time.Retribuzione:da concordare in base all'esperienza.About...
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Uri, Italia Cpl Taylor By Synergos Srl - Ricerca E Selezione Personale Qualificato A tempo pienoSENIOR REGULATORY CONSULTANT – LIFE SCIENCES (Ref. ANN )Reparto:Life Sciences – Consulenza e soluzioni digitali per il settore Life Sciences, sede in Italia.Località:Sedi principali: Roma, Verona, Milano.Si valutano profili provenienti da queste città.Contratto:Tempo indeterminato, full time.Retribuzione:da concordare in base all'esperienza.About the...
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Clinical Data Administrator
1 settimana fa
Uri, Italia Planet Pharma A tempo pienoTitle: Clinical Data Administrator - Data EntryLocation: La Spezia, ItalyClient: Leading CROType: 2-3 months contract - 20 hours per weekMain ResponsibilitiesEnter clinical study data into the designated system accurately and efficientlyReview source documents and extract relevant clinical informationCollaborate professionally with site staff, physicians,...
