Regulatory Affairs Jr. Specialist Consultant
ClinChoice · Mexico
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.