Regulatory Affairs Jr Analyst
hace 2 semanas
En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad.
La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y consumidores todos los días durante más de 130 años. Independientemente de su raza, creencia, orientación sexual, religión o cualquier otro rasgo, TÚ eres bienvenido en todos los puestos vacantes en la compañía de cuidado de la salud más grande del mundo.
Cuando te unes a Johnson & Johnson, tu movimiento podría significar nuestro próximo avance.
En Johnson & Johnson Medical Devices Companies, utilizamos nuestro alcance, escala y experiência para reinventar la manera en que se brinda atención médica y ayudar a las personas a vivir más tiempo y de manera más saludable.
En un entorno sumamente cambiante, establecemos conexiones entre la ciencia y la tecnología para combinar nuestros propios conocimientos especializados en soluciones quirúrgicas, ortopédicas e intervencionistas a fin de diseñar y ofrecer productos y servicios centrados en el paciente.
Estamos en esto de por vida.
Estamos cambiando la trayectoria de la salud humana, TU TAMBIÉN PUEDES.
**Estamos buscando al mejor talento para la posición REGULATORY AFFAIRS JR SPECIALIST que estará localizada en Lima, Perú.**
**Propósito**:Ejecutar estrategias regulatorias para la preparación y sometimiento de expedientes de renovaciones, cambios y nuevos registros sanitarios DE DISPOSITIVOS MEDICOS de conformidad con la normatividad de cada país y los planes comerciales de la compañía.
**Principales responsabilidades**:
- Ejecutar las estrategias regulatorias del proceso regulatorio de principio a fin (E2E), de conformidad con las leyes, regulaciones de cada país y requisitos organizacionales pertinentes para preparar los expedientes que garanticen el cumplimiento de las necesidades comerciales de la compañía.
- Tener una comunicación clara y oportuna con los demás miembros del equipo sobre el estatus de los procesos y posibles alertas que deban levantarse
- Coordinar con los consultores de RA los sometimientos en los países de los procesos a cargo
- Mantener actualizadas las bases de datos sobre los procesos a cargo
- Participar activamente en la reunión de planificación cada mes y ejecutar la preparación y envío del expediente para sometimiento de acuerdo con la fecha comprometida
- Apoyar en la solución de dudas referentes a la legislación local a los demás miembros del equipo de RA y aportar desde la perspectiva del Organismo Regulador local
- Dar respuesta a las cartas de deficiencia y requerimientos adicionales formulados por las autoridades sanitarias para los procesos a cargo
- Apoyar al equipo comercial local, de licitaciones y las áreas funcionales, aclarando preguntas relativas a la reglamentación para Dispositivos Médicos en el país
- Apoyo en los aspectos concernientes a registros sanitarios durante la recepción de la inspección organismos reguladores local o externo
- Realizar seguimiento presencial con las autoridades sanitarias locales, con el fin de acelerar trámites, resolver dudas o proponer soluciones con los oficiales de gobierno cuando sea necesario.
- Otras funciones asignadas por el jefe directo o Manager.
**Qualifications**:
**Requisitos**:
- Graduado en ciencias farmacéuticas / ciencias médicas, químicas o experiência equivalente.
- Inglés 80%
- Experiência laboral en Asuntos Regulatorios
- Conocimientos técnicos aplicados
- Perspicacia para los negocios
- Toma de decisiones y priorización
- Enfoque externo
- Liderar e influir
- Comunicación persuasiva
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