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Regulatory Affairs and Post market Surveillance

hace 1 semana

Bogotá, Bogotá D.E., Colombia B Braun A tiempo completo
**Descripción empresa**:
TRABAJAMOS CADA DÍA PARA SER UN PROVEEDOR COMPLETO PARA EL CUIDADO DE LA SALUD.
En B. Braun desarrollamos soluciones eficientes y buenas prácticas para el cuidado de la salud gracias a un diálogo constructivo con nuestros clientes y colaboradores.
A través de una estrecha relación y cooperación con los profesionales de la salud combinamos nuestros servicios y productos para ofrecer soluciones inteligentes y eficientes que cubran terapias completas y nos permitan seguir creciendo juntos.
**Misión del cargo**:
Garantizar el cumplimiento de las actividades referentes a la radicación de expedientes de registros sanitarios presentados ante el INVIMA,
**Funciones del cargo**:
Solicitar en conjunto con el líder del departamento los documentos requeridos para realizar los trámites propios del área como la renovaciones, modificación y nuevos registros sanitarios
Elaboración de expedientes para las solicitudes de los registros sanitarios de medicamentos, dispositivos médicos, cosméticos, alimentos regulares y alimentos con propósitos médicos especiales APME bajo la coordinación del líder del departamento.
Solicitar la traducción a la empresa autorizada de los documentos técnicos y legales seleccionados para la elaboración de los expedientes.
Preparar y radicar las solicitudes de registros y presentarlas en el aplicativo establecidos por el INVIMA.
Dar respuestas a los autos emitidos por el INVIMA, bajo la coordinación por parte del líder del departamento y hacer seguimiento al trámite.
Asegurar mitigar el riesgo de cancelación y/o suspensión de registros sanitarios asegurando las acciones para evitar poner en riesgo la venta de los productos de la compañía.
Verificar constantemente el correo de asuntos regulatorios donde el INVIMA notifica los actos administrativos de los tramites relacionado con la compañía.
Organizar y garantizar el correcto archivo de los expedientes de los productos radicados ante INVIMA.
Elaborar y presentar al líder inmediato los informes del estado de trámites ante INVIMA.
Elaborar las fichas técnicas y hojas de productos (que apliquen) de los productos registrados y comercializados por BBMCO, para la aprobación por parte del líder del departamento.
Creación, modificación de los documentos en SAP de los materiales relacionados con los registros sanitarios (COI), clientes autorizados para comercializar medicamentos de control especial (COC), venta de medicamentos de BBMCO (COF), previa delegación y autorización del líder del departamento.
Actualización de la información de registros y demás documentos en las bases de datos de asuntos regulatorios cada vez que se expida algún trámite al departamento.
**Requisitos**:
Experiência mínima de 1 año en el área de Asuntos Regulatorios
Profesional en Química Farmacéutica, Ingeniería Biomédica.
2 años de experiência manejando el programa de Vigilancia Post Mercado.
**Condiciones oferta**: