Ellysia Knott

I am a regulatory affairs and compliance specialist with hands-on experience building and improving QMS for medical devices, PPE, cosmetics, and luxury packaged goods, ensuring alignment with FDA, EN ISO 13485, UK, and global standards. I have supported regulatory submissions, managed UDIs, led audit responses, and driven CAPA and quality-monitoring initiatives to reduce risk and improve product quality.

Previously, I reviewed and maintained product labeling and ingredient documentation for U.S. and international markets, authored and revised SOPs, and performed microbiology quality control and internal audits in cGMP environments. I bring meticulous documentation practices, cross-functional collaboration, and a track record of implementing regulatory and quality solutions across both manufacturing and retail product lines.