Regulatory Affairs Analyst (Ciudad Juárez)

Regulatory Affairs Analyst

Job Function: Regulatory Affairs Group

All Job Posting Locations: Ciudad Juarez, Chihuahua, Mexico

Job Summary

The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets. This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as Technical Documents, amendments/supplements, annual reports, general correspondence, promotional materials, and other EU or US regulatory submissions. The individual will work closely with other Global Regulatory Affairs partners and with functional partners in Research and Development (R&D), Medical Affairs, Quality, Supply Chain, Marketing, and other functions.

Responsibilities

• Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bod...