Regulatory Affairs Specialist
hace 2 meses
Declaración DE&I
Durante más de 130 años, la diversidad, la equidad y la inclusión (DEI) han sido parte de nuestro tejido cultural en Johnson & Johnson y están integradas en la forma en que hacemos negocios todos los días. Arraigados en Nuestro Credo, los valores de DEI impulsan nuestra búsqueda de crear un mundo más saludable y equitativo. Nuestra fuerza laboral diversa y nuestra cultura de pertenencia aceleran la innovación para resolver los desafíos de atención médica más apremiantes del mundo.
Sabemos que el éxito de nuestro negocio (y nuestra capacidad para ofrecer soluciones significativas) depende de qué tan bien comprendamos y satisfagamos las diversas necesidades de las comunidades a las que servimos. Es por eso por lo que fomentamos una cultura de inclusión y pertenencia donde se valoran todas las perspectivas, habilidades y experiências y nuestra gente puede alcanzar su potencial.
En Johnson & Johnson, todos pertenecemos.
Estamos buscando al mejor talento para la posición Regulatory Affairs Specialist (UDI) que estará localizado en ciudades principales de Colombia.
Propósito: Responsable de ejecutar el proceso de presentación de documentos de aprobación de productos dentro de los requisitos de presentación. Acelera el proceso de aprobación resolviendo los problemas y garantizando el cumplimiento de las normativas e interpretaciones gubernamentales. Responsable de informar sobre UDI para los productos nuevos y establecidos.
Funciones:
- Ejecuta planes adecuados para la presentación de documentos de aprobación de productos a fin de garantizar una aprobación rápida y oportuna de los productos sanitarios y la continuidad del estado de aprobación de los productos sanitarios comercializados. 60%
- Presta apoyo como POC a las partes interesadas internas de acuerdo con las instrucciones de la dirección. 20%
- Participa y representa al departamento en las reuniones del proyecto de acuerdo con las instrucciones de la dirección. 20%
**Qualifications**:
Requerimientos:
- Formación pregrado titulado: Ciencias de la Salud. Farmacéutico, Bio-Ingeniero, Químico, et
- 3-5 años de experiência
- Inglés 80%
- Conocimientos avanzados de MS Office
- Conocimientos y gestión de UDI muy deseables
Experiência, aptitudes y competencias:
- Gran capacidad de organización.
- Capacidad de gestión de proyectos.
- Aprovecha un conocimiento práctico del entorno normativo, incluido el cumplimiento, las leyes, los reglamentos y las directrices actuales y propuestos, para preparar estrategias normativas conformes que estén en consonancia con los objetivos empresariales y de I+D de la empresa, incluida la consideración del entorno normativo global.
- Ejecuta estrategias normativas de conformidad con las leyes, los reglamentos y los requisitos organizativos pertinentes necesarios para obtener y mantener la situación legal en el mercado.
- Demuestra la capacidad de contribuir al desarrollo de planes estratégicos normativos eficaces y orientados a los resultados que estén en consonancia con los objetivos empresariales.
- Es consciente y receptivo a las diferencias culturales entre regiones y países.
- Sirve como experto técnico para proyectos de baja complejidad dentro de la función de trabajo.
- Capacidad de resolución de problemas.
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