About the role

Aplyr's Quick Take

This role is for a Regulatory Affairs Jr. Specialist Consultant focused on preparing and managing regulatory submissions for medical devices in Mexico. You'll work closely with a client and need to ensure compliance with local regulations, primarily COFEPRIS. It's an individual contributor role with a client-facing aspect.

Good fit

Ideal candidates are those with some experience in regulatory affairs, particularly in medical devices, and who are comfortable working independently while managing client relationships. A proactive and detail-oriented working style will help you succeed.

Worth noting

The position is a 12-month contract with the possibility of extension, which offers some job security. However, it's unclear how much support or training will be provided, so self-sufficiency is likely crucial.

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 & Tags

rust ai ios data product

Aplyr's read

ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
Synthesized from recent postings & public sources

What's promising

•ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
•The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
•ClinChoice's global presence allows employees to engage with international projects and clients.

What to watch

•Limited public information about ClinChoice's workplace culture and employee satisfaction.
•The company may face competition from larger CROs with more established reputations.
•Potential candidates might find limited career advancement information publicly available.

Why ClinChoice

•ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
•The company has a strong emphasis on statistical programming and regulatory affairs roles.
•ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ClinChoice

ClinChoice

clinchoice.com

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ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.