Regulatory Affairs Analyst
Se busca un Analista de Asuntos Regulatorios para gestionar la documentación, el cumplimiento y las presentaciones regulatorias de equipos médicos y suministros de laboratorio en Panamá.
Descripción del puesto
Regulatory Affairs Analyst
A leading company in the sale and distribution of medical equipment and laboratory supplies for clinical diagnostics is seeking a Regulatory Affairs Analyst to join its team.
Position Overview
The Regulatory Affairs Analyst will be responsible for managing activities related to regulatory documentation, compliance, and adherence to applicable regulatory requirements. This role also involves supervising and coordinating regulatory submissions before the relevant authorities.
This is a full-time, on-site position, based at our offices in Panama.
Key Responsibilities
- Manage and maintain regulatory documentation in compliance with applicable regulations.
- Review, analyze, and handle regulatory requirements related to medical devices and laboratory supplies.
- Prepare and submit regulatory filings and manage interactions with regulatory authorities.
- Ensure ongoing compliance with local regulatory standards.
- Coordinate regulatory processes related to sanitary registrations.
Requirements
- Solid knowledge of regulatory documentation and compliance requirements.
- Proven experience in regulatory affairs, including review and management of regulatory requirements.
- Experience with sanitary registration processes.
- Ability to prepare regulatory submissions and interact with regulatory agencies.
- Strong organizational skills, attention to detail, and ability to work effectively in a team.
- Advanced English proficiency.
- Bachelor’s degree in Biology or a related field.
Responsabilidades
- Gestionar y mantener la documentación regulatoria en cumplimiento con las regulaciones aplicables.
- Revisar, analizar y manejar los requisitos regulatorios relacionados con dispositivos médicos y suministros de laboratorio.
- Preparar y presentar solicitudes regulatorias y gestionar las interacciones con las autoridades reguladoras.
- Asegurar el cumplimiento continuo con los estándares regulatorios locales.
- Coordinar los procesos regulatorios relacionados con los registros sanitarios.