Sr Associate Specialist Regulatory Affairs

hace 2 semanas


Bogotá, Bogotá D.E., Colombia Ge Healthcare A tiempo completo

Job Description Summary GE HealthCare es un innovador líder mundial en tecnología médica y soluciones digitales.
Nuestro propósito es crear un mundo donde la atención médica no tenga límites.
Libere su ambición, convierta ideas en realidades que cambien el mundo y únase a una organización donde cada voz marca la diferencia y cada diferencia construye un mundo más saludable.
Job Description Funciones y responsabilidades Proporcionar información regulatoria para garantizar el cumplimiento de los requisitos reglamentarios en los países de las regiones PCP e INDI.
Proporcionar estrategias regulatorias para ayudar a guiar los sometimientos de dossiers regulatorios para garantizar aprobaciones de forma eficiente.
Mantener relaciones sólidas y efectivas con la autoridad reguladora local y representar a GEHC ante las partes interesadas clave.
Asegurar el cumplimiento normativo para garantizar que se cumplan todos los requisitos; trabajar con el personal pertinente para garantizar que se proporcionen aportes apropiados y oportunos.
Coordinar las actividades regulatorias regionales incluyendo sometimientos regulatorios y sus aprobaciones, así como soporte a los equipos comerciales regionales en temas estratégicos y operativos.
Evaluar y comunicar cambios propuestos a la normativa a través de Inteligencia Regulatoria y proponer estrategias.
Esforzarse por que las actividades de RA locales reflejen y apoyen las prioridades comerciales locales y comerciales globales.
Realizar reportes de Tecnovigilancia, hacer seguimiento hasta el cierre de los mismos.
Calificaciones Básicas Título Universitario en Química Farmacéutica, Ingeniería Biomédica o áreas afines.
Mínimo 2 años de experiencia en asuntos regulatorios en la industria de dispositivos médicos.
Nivel de Inglés Avanzado (C1 o mayor) Experiencia en reportes, requisitos y manejo del programa de tecnovigilancia en Colombia.
Características deseadas Fuertes habilidades analíticas.
Capacidad para trabajar sin supervisión en proyectos y actividades y en equipos multifuncionales.
Capacidad para priorizar, planificar y evaluar los entregables.
Enfoque en la ejecución de proyectos, tareas llegando a los resultados esperados.
Excelentes habilidades de comunicación y presentación verbal y escrita GE HealthCare es un empleador que ofrece igualdad de oportunidades donde la inclusión importa.
Las decisiones laborales se toman sin distinción de raza, color, religión, origen nacional o étnico, sexo, orientación sexual, identidad o expresión de género, edad, discapacidad, condición de veterano protegido u otras características protegidas por la ley.
Esperamos que todos los empleados vivan y respiren nuestros comportamientos: actúen con humildad y generen confianza; liderar con transparencia; cumplir con enfoque e impulsar la propiedad, siempre con integridad inquebrantable.
Nuestras recompensas totales están diseñadas para desbloquear su ambición brindándole el impulso y la flexibilidad que necesita para convertir sus ideas en realidades que cambiarán el mundo.
Nuestro salario y beneficios son todo lo que usted esperaría de una organización con fuerza y escala global, y estará rodeado de oportunidades profesionales en una cultura que fomenta la atención, la colaboración y el apoyo.
En GE HealthCare se prohíbe la solicitud de certificados médicos de no embarazo y Virus de Inmunodeficiencia Humana (VIH) como requisitos para el ingreso, permanencia o ascenso en el empleo.
Additional Information Relocation Assistance Provided: No #J-18808-Ljbffr



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