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Regulatory Affairs Associate (Mexico)

Regulatory Affairs Associate (Mexico)

Location Mexico
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Job ID
IS5672
Date posted
04/08/2026
Category
Regulatory Affairs
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Contract: 12 months 

Location: Mexico, Ciudad de México

Position Summary:
Support the preparation, review, and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS. This role enables timely approvals and ongoing maintenance of product registrations.

Key Responsibilities:

  • Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, modifications)

  • Follow up on submissions with regulatory authority (COFEPRIS)

  • Support interpretation of local and international regulations

  • Coordinate requests and activities with cross-functional teams

  • Maintain updated regulatory files and databases

Qualifications:

  • Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or a related field

Experience:

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

Technical Skills:

  • Knowledge of Mexican medical device regulations (COFEPRIS)

  • Understanding of medical device classification

  • Familiarity with NOMs and applicable standards

  • Intermediate to advanced English (technical reading required)

  • Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting)

  • Strong technical documentation management

Core Competencies:

  • Attention to detail

  • Organizational and documentation skills

  • Effective communication

  • Team collaboration

  • Proactivity

  • Learning agility

  • Adaptability


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