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Regulatory Affairs Specialist I - Jr Job Opening In Bogotá – Now Hiring Michael Page


Job description

Descripción

  • Gestionar y preparar documentación para registros regulatorios en dispositivos Medicos
  • Preparar, compilar y presentar los expedientes regulatorios de acuerdo con los requisitos de la autoridad sanitaria colombiana (INVIMA).
  • Coordinar con las autoridades sanitarias locales para garantizar el cumplimiento normativo.
  • Monitorear cambios regulatorios y evaluar su impacto en los productos existentes y nuevos.
  • Apoyar en la elaboración de estrategias regulatorias para productos en desarrollo.
  • Revisar y aprobar materiales relacionados con la comercialización desde una perspectiva regulatoria.
  • Colaborar con equipos internos para garantizar que los procesos cumplan con las normativas locales e internacionales.
  • Brindar apoyo regulatorio en actividades del Sistema de Gestión de Calidad (QMS), incluidas auditorías, procedimientos y vigilancia post-comercialización (PMS).
  • Mantener bases de datos regulatorias actualizadas con información precisa y completa.
  • Participar en auditorías regulatorias y responder a las consultas de las autoridades competentes.
  • Perfil buscado (h/m)

    El/la candidato/a seleccionado deberá cumplir los siguientes requisitos:

  • Título universitario en áreas relacionadas con Quimico Farmaceutico, química, farmacia o afines.
  • Nivel de Ingles Avanzado
  • Conocimientos en normativas regulatorias locales e internacionales aplicables al sector retail de dispositivos medicos.
  • Habilidad para trabajar de manera organizada y cumplir con plazos establecidos.
  • Manejo de herramientas tecnológicas y bases de datos regulatorias.
  • Capacidad para comunicarse de forma efectiva con equipos multidisciplinarios.
  • Qué Ofrecemos

  • Contrato a término indefinido.
  • Oportunidad de trabajar en un entorno profesional en Bogotá.
  • Participación en proyectos innovadores dentro del sector retail y ciencias de la vida.
  • Cultura empresarial enfocada en la excelencia y el cumplimiento normativo.
  • Capacitación y desarrollo profesional continuo.
  • Required Skill Profession

    Business Operations Specialists


    • Job Details

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    Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


    Real-time Regulatory Affairs Jobs Trends (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Regulatory Affairs in Bogotá, Colombia, highlighting market share and opportunities for professionals in Regulatory Affairs roles.

    240 Jobs in Colombia
    240
    56 Jobs in Bogotá
    56
    Download Regulatory Affairs Jobs Trends in Bogotá and Colombia

    Are You Looking for Regulatory Affairs Specialist I Jr Job?

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    6. Respect for human rights

    7. Obeying Colombia laws and regulations

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