Regulatory Affairs
hace 5 días
The companyAre 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 OrganizationSi los siguientes requisitos del puesto y la experiencia coinciden con sus habilidades, por favor, asegúrese de enviar su solicitud sin demora.Work 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-centreWe 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. xsgfvud Join hundreds of fellow regulatory, quality and clinical professionals in Elemed's RQC Network. We are an equal opportunity employer and value diversity at our company .
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Regulatory Affairs
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Regulatory Affairs Trainee
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Especialista en Regulatory Affairs
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Sr. Regulatory Affairs
hace 2 semanas
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Regulatory Affairs
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Barcelona, Barcelona, España LHH A tiempo completoDesde la división de LifeSciences de LHH Recruitment Solutions estamos buscando el perfil de Regulatory Affairs con experiencia en sector cosmética Zona de trabajo: Vallés Oriental.FUNCIONES PRINCIPALES1- Preparación de documentación necesaria para registro a nivel internacional:Gestión y seguimiento los registros internacionales. Valorar los casos que...
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hace 1 semana
Barcelona, España Alcon A tiempo completo¿Estás estudiando un Máster o Posgrado en Regulatory Affairs o Farmacia? ¿Estás en búsqueda de prácticas? ¿Quieres unirte a una Multinacional líder del sector Medical Device? ¡Esta es tu oportunidad! Ofrecemos un proyecto de prácticas mediante un convenio de 12 meses de duración que te permitirá poner en práctica y desarrollarte como...
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Regulatory Affairs
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Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory Affairs Se responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
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Regulatory Affairs Manager
hace 2 días
Barcelona, España Jordan martorell s.l. A tiempo completoJob Title:¿Tiene las habilidades necesarias para este puesto? Lea todos los detalles a continuación y presente su candidatura hoy mismo.European Regulatory Affairs ManagerLocation:Madrid, Spain - HybridRemuneration:Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in...
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Regulatory Affairs Officer Pharma
hace 16 horas
Barcelona, España Page Personnel España A tiempo completoReporting to the Regulatory Affairs Manager, he/she will be responsible for preparing, managing and submitting the documentation required within a registration dossier to the Health Authorities, in accordance with the current legislations. - Report to Head of Regulatory Department - Capability to maintain fluid and frequent contact with the client & to find...
