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Sr. Regulatory Affairs Specialist

Glaukos • Aliso Viejo, CA, US • published 2026-11-03 09:17:09.185759

Description

The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs. **How You’ll Contribute:** The Sr. RA Specialist is responsible for preparation of regulatory submissions (primarily domestic). Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs. **What You’ll Do:** * Assists with preparation of 510(k), IDE's, PMA regulatory submissions required by FDA * Assists with FDA establishment registration and device listing submissions * Support recurring US regulatory reports/requirements (e.g. PMA annual reports) * Prepare and maintain required materials including but not limited to: + FDA export certificates (CFG) requests + Document legalization + License renewals (including state licenses) + Country approval list + Other regularly maintained registrations and licenses * Support international registrations as requested * Internal review of labeling, advertising, and document change orders as needed * Coordinate information requests from FDA and inter...

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