Senior Regulatory Affairs Leader
2 weeks ago
Flexibilidad Laboral: Híbrido
Actualmente estamos buscando un Senior Regulatory Affairs Leader para nuestra división de Instrumentos.
¿Quiénes somos?
- Pensadores estratégicos. Personas que disfrutan analizar datos o tendencias con el propósito de planificación, pronóstico, asesoramiento, presupuestación, informes u oportunidades de ventas.
- Orquestadores orientados a objetivos. Personas que pueden coordinar y enfocar efectivamente el trabajo de empleados calificados hacia un objetivo importante, priorizando las actividades correctas que conducen al éxito.
- Evaluadores orientados a los negocios. Personas que interpretan efectivamente la información para demostrar los efectos de iniciativas comerciales, regulaciones y tendencias de la industria para equipos de ventas, gestión y liderazgo.
Como Senior Regulatory Affairs Leader, apoyarás el desarrollo de nuevos productos para lanzamientos tanto nacionales como internacionales, contribuyendo al desarrollo y actualización de estrategias regulatorias basadas en cambios normativos. Serás considerado el recurso del equipo regulatorio global, asegurando el cumplimiento regulatorio mediante evaluaciones y presentaciones exhaustivas relacionadas con autorizaciones de productos ante autoridades competentes.
- Evalúa las conexiones entre tendencias globales, sociales y económicas; preocupaciones de los interesados y requisitos regulatorios; y las implicaciones para la estrategia regulatoria.
- Participa en actividades de defensa de carácter más avanzado y estratégico.
- Desarrolla y actualiza estrategias regulatorias globales, regionales y multicountry, alineando las estrategias regulatorias con las estrategias organizacionales.
- Proporciona orientación para integrar consideraciones regulatorias en la estrategia de entrada y salida de productos a nivel global.
- Identifica rutas regulatorias para diseños de productos iniciales y proporciona insumos a las partes interesadas internas.
- Analiza la adecuación de las rutas regulatorias propuestas y la estrategia para los diseños de productos iniciales, recomendando cambios o refinamientos basados en resultados regulatorios iniciales.
- Evalúa todos los requisitos y posibles obstáculos para el acceso al mercado y distribución, desarrollando soluciones para abordar obstáculos anticipados.
- Evalúa el impacto de las regulaciones cambiantes en estrategias pre y post aprobación.
- Proporciona comprensión profunda y capacidad para incorporar estrategias regulatorias que aceleren el desarrollo de productos destinados a condiciones médicas graves o que aborden necesidades médicas no satisfechas.
- Negocia con autoridades regulatorias sobre cuestiones complejas a lo largo del ciclo de vida del producto.
- Establece relaciones de trabajo e interfaces con múltiples organizaciones gubernamentales y no gubernamentales que impactan el acceso al mercado y la distribución.
- Identifica la necesidad de desarrollar y ejecutar nuevos procedimientos regulatorios y procedimientos operativos estándar.
- Desarrolla y gestiona programas que capaciten a las partes interesadas sobre requisitos regulatorios actuales y nuevos para asegurar el cumplimiento en toda la organización.
- Proporciona insumos estratégicos y orientación técnica sobre requisitos regulatorios globales a los equipos de desarrollo de productos.
- Evalúa riesgos de problemas de seguridad de productos y clínicos durante las fases clínicas y recomienda soluciones regulatorias.
- Evalúa cambios propuestos en preclínicos, clínicos y fabricación para soluciones de presentación regulatoria.
- Revisa y evalúa propuestas a autoridades regulatorias sobre rutas regulatorias y planes clínicos.
- Monitorea la implementación de estrategias regulatorias en relación con problemas de seguridad de productos y clínicos.
- Proporciona conocimiento y análisis crítico de inspecciones preaprobatorias y relaciones con investigadores clínicos.
- Proporciona orientación regulatoria sobre estrategias para reclamaciones/etiquetado de productos propuestos.
- Asegura que los datos clínicos y no clínicos sean consistentes con los requisitos regulatorios y respalden las reclamaciones del producto propuesto.
- Gestiona el desarrollo de registros electrónicos (eCTD) y en papel.
- Asegura que existan políticas y procedimientos para la revisión y aprobación interna de presentaciones regulatorias.
- Lidera negociaciones clave e interacciones con autoridades regulatorias durante todas las etapas del desarrollo y proceso de revisión.
- Prepara equipos multifuncionales para interacciones con autoridades regulatorias, incluidos paneles/comités asesores.
- Posee y aplica conocimientos estratégicos y avanzados, habilidades y comprensión de los marcos regulatorios y legales, requisitos regulatorios, legislación, procesos y procedimientos.
- Título universitario requerido, preferiblemente en Ingeniería, Ciencia o relacionado.
- MS en Ciencias Regulatorias o título avanzado preferido.
- Más de 9 años de experiencia en una industria regulada por la FDA requerida; preferiblemente con dispositivos médicos.
- Más de 7 años de experiencia en Asuntos Regulatorios de Dispositivos Médicos requerida.
- Experiencia previa redactando presentaciones regulatorias a la FDA requerida.
- Experiencia interactuando con agencias regulatorias requerida.
- RAC(s) deseado.
- Comprensión profunda de las Regulaciones del Sistema de Calidad (21 CFR), Directivas de Dispositivos Médicos (MDD) y orientación MEDDEV.
- Comprensión profunda de otras regulaciones relacionadas con la Autorización de Mercado Previo y Soporte Post Mercado.
- Experiencia previa con dispositivos médicos de Clase II/III requerida, experiencia con software o PPE deseada.
- Habilidades avanzadas en PC con dominio del Paquete de Microsoft Office, incluyendo Excel.
Stryker Corporation es un empleador que ofrece igualdad de oportunidades. Los solicitantes calificados recibirán consideración para el empleo sin distinción de raza, etnia, color, religión, sexo, identidad de género, orientación sexual, nacionalidad, discapacidad o estatus de veterano protegido.
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