Regulatory and Quality Compliance Manager
hace 7 días
The company¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación.Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons on the market? Here is a rare and great opportunity to join an international leader in surgical technology and be part of this company’s regional growth strategy in Spain and Portugal and be visible at the EMEA-level. As the Regional QARA Lead for the IBERIAN region, you will be based at their Spain branch office in Barcelona, where they have centralised sales, marketing, customer success teams all in one place.This is a company-critical role and your past experiences in registrations can help the company to reach their business goals for the EMEA region.You will be responsible for the quality system of the sales office in Barcelona as well as supporting the registrations for Spain. Furthermore, you are part of the EMEA Quality Assurance and Regulatory affairs team, for this region you will be responsible for collecting clinical data from surgeons to assist the HQ in the US with clinical surveillance.In this role you will report directly to the Sr Director Quality Assurance and Regulatory Affairs InternationalMaintain the Quality Management System for their Spanish OrganizationWork with the Regional Commercial leader to ensure the medical device portfolio remain commercially available and compliantLeading clinical data collection and surgeon feedback processes for submission and PMCFsPrepare and lead the quality management review meetingsTraining and coaching people in RAQA functions in other EMEA offices on the procedures and processesIdentify local regulatory requirements and lead impact assessment which is driving quality management system changesExecute Local regulatory registrations where necessaryEMEA regulatory affairs activities concerning importer and authorized representative requirementsAt least 5 years in a quality assurance or regulatory affairs role in the medical device industryLed the RAQA operations or projects for medical devicesFluent written & spoken in Spanish and English (bonus if Portuguese and Catalan as well)Office-presence 3 days per week in Barcelona city-centre We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.#At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.Learn and develop as a regulatory, quality or clinical professional with 1:1 mentorship from a highly experienced mentor. Our mentors are some of the most inspirational and talented senior professionals in the medical device and IVD industry. Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network. xsgfvud We are an equal opportunity employer and value diversity at our company.
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Regulatory and Quality Compliance Manager
hace 7 días
Barcelona, España Elemed A tiempo completoThe company¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación.Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are...
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Regulatory Compliance Manager
hace 7 días
Barcelona, España ARTO A tiempo completoPosition OverviewTodas las habilidades, cualificaciones y experiencia relevantes que necesitará un candidato seleccionado se enumeran en la siguiente descripción.The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality...
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Quality and Regulatory Director
hace 7 días
Barcelona, España ARTO A tiempo completoPosition Overview Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura. The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control,...
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Quality and Regulatory Director
hace 1 semana
Barcelona, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
hace 7 días
Barcelona, España ARTO A tiempo completoPosition Overview ¿Tiene las siguientes habilidades, experiencia e impulso para tener éxito en este puesto? Descúbralo a continuación. The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance,...
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Quality and Regulatory Director
hace 1 semana
Barcelona, España ARTO A tiempo completoPosition Overview Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura. The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control,...
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Quality and Regulatory Director
hace 2 semanas
Barcelona, España ARTO A tiempo completoPosition OverviewHaga clic en "Solicitar" a continuación para enviar su candidatura. Asegúrese de que su CV está actualizado y de que ha leído primero las especificaciones del puesto.The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position...
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Quality and Regulatory Director
hace 1 semana
Barcelona, España ARTO A tiempo completoPosition OverviewHaga clic en "Solicitar" a continuación para enviar su candidatura. Asegúrese de que su CV está actualizado y de que ha leído primero las especificaciones del puesto.The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position...
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Quality and Regulatory Director
hace 1 semana
Barcelona, España ARTO A tiempo completoPosition OverviewHaga clic en "Solicitar" a continuación para enviar su candidatura. Asegúrese de que su CV está actualizado y de que ha leído primero las especificaciones del puesto.The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position...
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Quality and Regulatory Director
hace 12 horas
Barcelona, España ARTO A tiempo completoPosition OverviewThe Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
