Senior Director, Quality & Regulatory Excellence

Cytovale, Inc. is seeking a senior quality and regulatory leader to own the QMS and lead FDA/ISO compliance for the IntelliSep system. You will shape a strategic regulatory roadmap, oversee audits, and drive continuous improvement across quality functions in a Bay Area onsite setting. This senior role requires extensive experience in medical devices, quality systems, and regulatory submissions, with a focus on scalable processes and strong leadership across QA/RA teams.