Regulatory Affairs Senior Specialist

2 weeks ago

Carlsbad, United States Bolt Medical Full time

ATENCIÓN: SOLO CANDIDATOS DIRECTOS, SI ESTÁS INTERESADO, APLICA A TRAVÉS DE LA PUBLICACIÓN DEL TRABAJO. NO MENSAJES DIRECTOS.

RECLUTADORES: NO CONTACTAR.

El Especialista Senior en Asuntos Regulatorios es fundamental para llevar a cabo las actividades de presentación de solicitudes de aprobación de productos a nivel mundial para la empresa, cumpliendo con todas las normativas aplicables. Este rol es clave para el éxito de la organización en la obtención de autorizaciones y aprobaciones de mercado para todos los productos. Las responsabilidades incluyen la preparación de presentaciones regulatorias tanto nacionales como internacionales para respaldar las estrategias regulatorias de la empresa.

  • Representar al departamento de Asuntos Regulatorios en equipos de proyectos y colaborar con el equipo para asegurar la alineación de la estrategia regulatoria global con los objetivos del equipo.
  • Identificar los requisitos regulatorios para los mercados designados y trabajar de manera independiente en el desarrollo de estrategias regulatorias globales para proyectos asignados, así como en la formulación de soluciones.
  • Redactar, revisar y presentar solicitudes regulatorias para garantizar que los dispositivos estén disponibles comercialmente en los mercados asignados, de acuerdo con la estrategia regulatoria aprobada.
  • Establecer comunicación con agencias regulatorias sobre asuntos administrativos y rutinarios.
  • Documentar, consolidar y mantener la comunicación verbal y escrita con las agencias regulatorias.
  • Revisar documentos de órdenes de cambio y evaluar su impacto en las aprobaciones regulatorias actuales.
  • Examinar material promocional y etiquetado para asegurar el cumplimiento regulatorio.
  • Desarrollar y mantener archivos y registros regulatorios.
  • Contribuir en el desarrollo, edición o revisión de procesos regulatorios.
  • Cumplir con las leyes y regulaciones aplicables, adherirse a los procesos y requisitos del Sistema de Gestión de Calidad, y demostrar ética e integridad en todos los asuntos y niveles de la organización.
  • Promover de manera constante la colaboración, la positividad, la responsabilidad y la ingeniosidad.
  • Demostrar respeto mutuo, comunicación continua y una actitud positiva tanto con los miembros del equipo interno como con los clientes.

Educación:

Título universitario mínimo en una disciplina relacionada; o combinación equivalente de educación y experiencia.

Experiencia Requerida:

  • De 7 a 10 años de experiencia profesional en regulación/calidad en la industria de dispositivos médicos, farmacéutica/biotecnológica o en una agencia reguladora.
  • Experiencia significativa en regulación clínica y regulatoria, tanto nacional como internacional, incluyendo experiencia con dispositivos de Clase II y III.
  • Comunicación escrita efectiva específica para presentaciones regulatorias de dispositivos médicos.
  • Capacidad para comprender las responsabilidades del puesto, poseer las habilidades/conocimientos necesarios y estar dispuesto a seguir aprendiendo y creciendo en el campo.
  • Habilidad para gestionar una carga de trabajo significativa y obtener resultados positivos, asumiendo responsabilidades adicionales y gestionando prioridades según sea necesario.
  • Precisión, atención al detalle, compromiso con altos estándares de calidad y proactividad en la búsqueda de soluciones para lograr resultados exitosos.
  • Excelentes habilidades de comunicación verbal y escrita, con capacidad para producir informes/información precisa y puntual, y compartir información de manera efectiva con otros.
  • Habilidades excepcionales de escucha, con capacidad para buscar retroalimentación constructiva, construir relaciones, promover el trabajo en equipo y mantener una mentalidad flexible y abierta.
  • Capacidad para seguir planes realistas, establecer metas, gestionar recursos, planificar contingencias, coordinar y cooperar con otros.
  • Capacidad para trabajar de manera reflexiva bajo presión y en plazos ajustados.

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