Senior Director, Quality & Regulatory Excellence

Cytovale; San Francisco (CA); On-site; USD 260,000 - 360,000; Full time

Job summary

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.

Qualifications

• Bachelor's degree in engineering; 10+ years in quality leadership for medical devices.
• Proven track record leading QA/RA with audit readiness and inspections.
• Deep knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and ISO 14971.
• Experience with design change, process validation, and CAPA systems.
• Strong data-driven problem solving and cross-functional collaboration.

Responsibilities

• Own the QMS, CAPA, nonconformance, deviation management and change control.
• Lead audits, registrations, and inspections with a proactive readiness posture.
• Develop a 18- to 24-month regulatory roadmap for 510(k)s and PCCPs.
• Direct design quality, allocate resources, and embed QE in project teams.
• Coach and develop a high-performing quality organization.

Skills

Quality leadership

Cross-functional leadership

Risk analysis

Root cause analysis

FDA QMSR knowledge

Process validation

Quality engineering

Education

Bachelor's degree in engineering

MBA or related advanced degree

Tools

eQMS platforms

AI-enabled quality tools

Job description

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.