Regulatory Affairs Jr. Specialist Consultant

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

Position Summary / Resumen del puesto:

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.

Key responsabilities / Responsabilidades principales:

• 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.

Qualifications / Requisitos:

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.

Experience / Experiencia:

Minimum 1 year of experience in regulatory affairs, quality or medical device industry.

Technical skills / Conocimientos técnicos:

• 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).

Core competencies / competencias clave:

• Attention to detail.
• Organizational and documentation skills.
• Effective communication.
• Team collaboration
• Learning Agility.