Regulatory Affairs Specialist

hace 5 días


España Antal International Network A tiempo completo

Responsabilidades: Preparar, revisar y presentar la documentación técnica requerida para la obtención y mantenimiento de aprobaciones regulatorias (CE, MDR, FDA, etc.). Garantizar que los productos cumplan con todas las regulaciones locales e internacionales, incluyendo normativas de la Unión Europea (MDR) y otros mercados clave. Mantener relaciones con autoridades regulatorias, agencias de certificación y organismos de salud para facilitar la aprobación de productos. Mantenerse al día con los cambios en la legislación y regulaciones que puedan impactar el portafolio de productos y asesorar a los equipos internos sobre su implementación. Colaborar estrechamente con el equipo de calidad para asegurar que los sistemas de gestión de calidad (ISO 13485) se mantengan actualizados y en cumplimiento. Gestionar la creación y mantenimiento de expedientes técnicos y dossiers regulatorios, garantizando la disponibilidad de documentación precisa y actualizada. Requisitos: Licenciatura en ciencias de la salud, farmacia, biotecnología, derecho sanitario o áreas relacionadas. Mínimo de 3-5 años de experiencia en asuntos regulatorios, preferiblemente en dispositivos médicos o productos farmacéuticos. Profundo conocimiento de regulaciones europeas (MDR/IVDR), normativas internacionales y procesos de aprobación de productos. Capacidad para interactuar eficazmente con autoridades regulatorias y equipos multidisciplinarios. Fluidez en español e inglés, tanto escrito como hablado. Residencia en Madrid o disposición para relocalizarse. Ofrecemos: Oportunidad de trabajar en el desarrollo de soluciones tecnológicas de vanguardia que impactan de forma positiva en el sector de la salud. Un ambiente colaborativo y en crecimiento, con un equipo de profesionales altamente cualificados. Planes de formación continua en asuntos regulatorios y oportunidades para crecer dentro de la organización. Salario competitivo acorde al mercado, con beneficios adicionales y flexibilidad. ¿Interesado? Envía tu CV y únete a un equipo que está marcando la diferencia en la atención médica a nivel global.
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