Regulatory Affairs Jr. Specialist Consultant
Core
Support the preparation, review, and follow-up of regulatory submissions for medical devices to ensure compliance with COFEPRIS regulations.
Role type
Junior Regulatory Affairs Specialist Consultant
Builds
Regulatory submissions and product registrations for medical devices
Domain
Medical Devices / Regulatory Affairs (Mexico)
Deliverable
client delivery
Required skills
Mexican medical device regulations (COFEPRIS), Medical device classification, NOMs and standards, Intermediate-advanced English, Intermediate Excel
Preferred skills
None stated
Technologies
Excel
Responsibilities
Prepare and compile regulatory documentation for COFEPRIS submissions, 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