Regulatory Device CMC Manager

Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID: -OTHLOC-7302-2DR

Job Responsibilities

General Position Summary

The Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for device part of the combination device. This role also provides regulatory support and guidance to various cross‑functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Key Duties & Responsibilities

• Reviews device sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory device strategies for commercial products
• Works with regulatory colleagues in development of global regulatory...