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Somos un laboratorio especializado en la elaboración y comercialización de productos sanitarios, cosméticos y de cuidado personal con fuerte presencia a nivel internacional. Apostamos por la innovación, la eficacia, la calidad y la mejora continua, ofreciendo productos seguros, eficaces y comprometidos con el bienestar de las personas. Nuestro objetivo es satisfacer las necesidades y expectativas de nuestros clientes, trabajando siempre por un progreso institucional a través del desarrollo personal y profesional de nuestros colaboradores y de una producción que cuente con altos estándares de calidad. Buscamos ampliar nuestro equipo con un/aRegulatory Affairs Specialist - Medical Device, que en dependencia del responsable de Garantía de Calidad,garantice el cumplimientos normativo de productos sanitariosy cosméticos tanto en mercado nacional como internacional, asegurando el cumplimientos de la legislación vigente a lo largo de todo el ciclo de vida del producto. Responsabilidades Registro y autorización de productos sanitarios y cosméticos en los mercados de destino. Elaboración, mantenimiento y actualización de la documentación técnica relacionada. Identificación, registro, investigación y cierre de incidencias. Propuesta y seguimiento de acciones correctivas y preventivas (CAPA). Apoyo en la validación de procesos y calificación de equipos. Seguimiento y análisis de cambios normativos a nivel nacional e internacional. Soporte regulatorio en desarrollo de nuevos productos. Interlocución con autoridades sanitarias, distribuidores y organismos notificados. Participación en auditorías internas y externas. Otras tareas inherentes al departamento. Requisitos: Grado/Licenciatura en Farmacia, Química, Biología, Biotecnología, Ingeniería Química o similar. Mínimo 2 años en puesto similar desarrollando funciones descritas en producto sanitario. Muy valorable experiencia en sector Cosmético. Conocimiento básico de normativa aplicable (Reglamento cosmético, ISO, etc.). ISO 13485 , ISO 22716 Manejo de herramientas ofimáticas y de gestión documental Nivel avanzado de inglés técnico
