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IVD Regulatory Affairs Specialist
hace 3 meses
Desde Ambit BST, estamos buscando un/a Regulatory Affairs Technician para uno de nuestros clientes (Empresa especializada en el desarrollo, producción y comercialización de reactivos para diagnóstico in-vitro).
Participarás en la preparación de la documentación necesaria para la presentación de solicitudes reglamentarias en todo el mundo y en la gestión de todos los aspectos relacionados con la importación/exportación/aduana de materias primas y productos de IVD de acuerdo con los requisitos reglamentarios aplicables.
TAREAS :
Apoyar al Director de Asuntos Regulatorios/Director Técnico en las actividades de desarrollo de producto y cumplimiento de las normas regulatorias en todo el ciclo de vida de un producto. Así como también en tareas relacionadas con estudios clínicos. Preparación de los informes y dosieres técnicos que sustentan la certificación de productos conforme a regulaciones vigentes (Ej. Marcado CE, FDA, reportes anuales) aportando asesoría técnica. Elaborar Evaluación de Funcionamiento (PEP/PER) y participar en la revisión de gestión de riesgos de diseño de los productos, en lo que respecta al impacto regulatorio. Recomendar y gestionar, en su caso, cambios en los procedimientos/documentos de la empresa (sistema de calidad y cumplimiento) para cumplir con las normas, directrices y/o estándares vigentes. Comunicación con las autoridades sanitarias competentes y organismos notificados para seguimiento, mantenimiento y obtención marcado CE y autorizaciones solicitadas. Participar en la elaboración y revisión del material de producto, etiquetado (etiquetas /instrucciones de uso) y hojas de especificaciones conforme a las regulaciones vigentes y políticas del cliente Participar en el seguimiento de trámites pre y post autorización de los productos de la empresa. Participar en la generación de la documentación que se derive de la aplicación del Sistema de Vigilancia, ayudando al Director Técnico. Coordinar y ejecutar el proceso de registro de productos en mercados fuera de la Unión Europea (ROW). Colaborar con diferentes departamentos dentro de la empresa y participar en equipos interdisciplinarios (I+D, Producción, Marketing, Ventas, Control de calidad y Garantía de calidad) para respaldar el cumplimiento de los objetivos comerciales dentro del marco regulatorio. Elaborar procedimientos (PNTs) relacionados con la actividad regulatoria. Apoyar a los clientes con cualquier aspecto regulatorio. Apoyar auditorías internas y externas, validaciones y análisis de riesgo de productos Brindar orientación y asesoramiento técnico sobre asuntos regulatorios a otros miembros del equipo. Supervisar y entrenar al personal junior en el departamento de Regulatory Affairs.REQUISITOS :
Formación superior en Ingeniería y/o Ciencias Experimentales y/o de la Salud Experiencia en Regulatory Affairs. Conocimiento y experiencia en IVDD, IVDR (2017/746) y ISO 13485. Experiencia en la redacción, presentación y aprobación de dosieres técnicos a las autoridades sanitarias/agencias regulatorias/organismos notificados. Excelentes habilidades de comunicación escrita y verbal en inglés. Disfruta aprender cosas nuevas. Disposición para trabajar en corporaciones multifuncionales y de ritmo rápido Capacidad de realizar “ Technical writing” y capacidad de síntesis.HORARIO :
Jornada completa de Lunes a Viernes. CONDICIONES :
Nuestro objetivo es que estés bien en todos los sentidos
