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Cumplimiento y Riesgo en Conyers
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Gerente Asociado de Asuntos Regulatorios (Atlanta)63392017521539120
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Gerente Asociado de Asuntos Regulatorios (Atlanta)
¿Quién es CorDx?     CorDx es una organización biotecnológica multinacional enfocada en expandir los límites de la innovación y el suministro en salud global. Con más de 2.100 empleados en todo el mundo, atendiendo a millones de usuarios en más de 100 países, CorDx ofrece soluciones rápidas de pruebas y dispositivos médicos de atención primaria utilizadas en la detección de enfermedades infecciosas como la COVID-19, embarazo, drogas de abuso, biomarcadores y más. CorDx está a la vanguardia de la tecnología, la inteligencia artificial y la ciencia de datos con el objetivo de ofrecer soluciones diagnósticas para algunas de las preguntas más críticas en el ámbito de la salud.     Tipo de empleo: Tiempo completo   Título del puesto: Gerente Asociado de Asuntos Regulatorios Ubicación: Presencial - Atlanta, GA Resumen del puesto: El Gerente Asociado de Asuntos Regulatorios apoyará el desarrollo, revisión y presentación de documentos regulatorios para productos de dispositivos médicos y diagnóstico in vitro (IVD). Este puesto ayudará a gestionar proyectos regulatorios, asegurando el cumplimiento con la FDA, la ISO 13485 y otros requisitos regulatorios globales. El gerente asociado trabajará de forma transversal con equipos internos y socios externos para apoyar la aprobación de productos y mantener el cumplimiento regulatorio durante todo el ciclo de vida del producto. Principales responsabilidades: Ayudar en la preparación, revisión y presentación de documentación regulatoria para nuevos productos, cambios en productos y cumplimiento continuo. Apoyar el proceso de presentación regulatoria para 510(k), archivos técnicos y otras presentaciones regulatorias. Proporcionar orientación regulatoria a equipos multifuncionales durante el desarrollo del producto y actividades posteriores al mercado bajo la dirección de la gerencia superior. Ayudar a supervisar y gestionar los plazos de presentación, planes de proyectos regulatorios y documentación. Mantenerse informado sobre cambios en la FDA, ISO 13485, IVDR y otras regulaciones globales, comunicando actualizaciones relevantes al equipo. Realizar evaluaciones regulatorias para modificaciones de productos y ayudar a definir estrategias de presentación adecuadas. Participar en auditorías internas y externas, inspecciones y comunicaciones con agencias regulatorias según se asigne. Contribuir al mantenimiento de archivos regulatorios y registros de presentaciones de acuerdo con procedimientos internos y regulaciones. Puede proporcionar supervisión y mentoría a personal junior o especialistas en proyectos asignados. Requisitos Educación: Título universitario en Asuntos Regulatorios, Ciencias de la Vida, Ingeniería o campo relacionado. Se prefiere título de maestría. Experiencia profesional: 4 a 6 años de experiencia en asuntos regulatorios en la industria de dispositivos médicos o IVD. Experiencia apoyando o gestionando presentaciones 510(k) y presentaciones regulatorias. Conocimiento de las regulaciones de la FDA (21 CFR Parte 820), ISO 13485 y regulaciones internacionales de dispositivos médicos. Se valora experiencia en auditorías e inspecciones regulatorias. Habilidades y competencias: Habilidades sólidas de organización, gestión de documentos y coordinación de proyectos. Excelentes habilidades de comunicación, resolución de problemas y colaboración multifuncional. Orientado al detalle, con capacidad para gestionar múltiples proyectos y prioridades regulatorias. Dominio de Microsoft Office y sistemas de gestión de documentos regulatorios. Capacidad para trabajar de forma independiente y proactiva, buscando orientación en temas complejos. Beneficios Paquete salarial altamente competitivo. Seguro médico, dental y de visión integral. Plan 401(k) con generosas contribuciones de la empresa. Política flexible de tiempo libre remunerado (PTO). Otros beneficios sustanciales. Declaración de igualdad de oportunidades: Somos un empleador que ofrece igualdad de oportunidades y nos comprometemos con la inclusión y la diversidad. No discriminamos por raza, género, religión, orientación sexual, edad, color, estado civil, condición de veterano, discapacidad, origen nacional o cualquier otra característica protegida.
Atlanta, GA, USA
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