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.
Skills Required
- Bachelor's degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related
- Minimum 1 year of experience in regulatory affairs, quality or medical device industry
- Mexican medical device regulations knowledge (COFEPRIS)
- Intermediate-advanced English (technical reading required)
- Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting)
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
ClinChoice Insights
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
