Regulatory Affairs Jr. Specialist Consultant (Medtech)

TL;DR

Regulatory Affairs Jr. Specialist Consultant (Medtech): Supporting the preparation, review, and follow-up of regulatory submissions for medical devices, ensuring compliance with COFEPRIS regulations. Focus on timely approvals and maintenance of product registrations, coordinating with cross-functional teams, and interpreting local and international regulations.

Location: Ciudad de México, México

Company

hirify.global is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.

What you will do

• 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.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.
• Minimum 1 year of experience in regulatory affairs, quality or medical device industry.
• Mexican medical device regulations (COFEPRIS).
• Medical device classification.
• NOMs and standards aplicable.
• English: Intermediate-advanced (technical reading required).
• Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).

Culture & Benefits

• Working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring.