re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios
Location / Ubicación: Ciudad de México, México
Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations.
Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios.
Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes).
Follow up on submissions with regulatory authority (COFEPRIS).
Support interpretation of local and international regulations.
Support coordination of requests and activities with cross-functional teams.
Maintain updated regulatory files and databases.
Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones).
Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS).
Apoyar en la interpretación de normativas locales e internacionales.
Apoyar la coordinación de solicitudes y actividades con áreas internas.
Mantener actualizados archivos regulatorios y bases de datos.
Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.
Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.
Minimum 1 year of experience in regulatory affairs, quality or medical device industry.
Mexican medical device regulations (COFEPRIS).
Medical device classification.
NOMs and standards aplicable.
Intermediate-advanced English (technical reading required).
Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).
Attention to detail.
Organizational and documentation skills.
Effective communication.
Team collaboration
Learning Agility.
Originally posted by ClinChoice. View original posting
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