Tech Stack

Description

You will support the preparation, review, and follow-up of regulatory submissions for medical devices, ensuring compliance with COFEPRIS regulations to enable timely approvals and maintenance of product registrations.

Requirements

• Bachelor's in Chemistry, Pharmaceutical Chemistry, or related field
• Minimum 1 year experience in regulatory affairs or medical device industry
• Knowledge of Mexican medical device regulations (COFEPRIS)
• Intermediate-advanced English
• Intermediate Excel skills

Responsibilities

• Prepare and compile regulatory documentation for COFEPRIS submissions
• Follow up on submissions with COFEPRIS
• Interpret local and international regulations
• Coordinate requests with cross-functional teams
• Maintain regulatory files and databases