Prepare COFEPRIS submissions for medical devices (registrations, renewals, changes).
Follow up on COFEPRIS submissions with authorities.
Interpret local and international regulations for devices.
Coordinate regulatory requests with cross-functional teams.
Maintain updated regulatory files and databases.

🎯 Requirements

Bachelor's degree in Chemistry, Pharmacy, Biomedical Eng, Biotech, or related field.
Minimum 1 year in regulatory affairs, quality or medical device industry.
COFEPRIS regs, medical device classification, NOMs/standards.
Intermediate-advanced English (technical reading).
Excel skills (data tracking, pivot tables, basic formulas).

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