Senior Director, Quality & Regulatory Compliance

Cytovale; South San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Cytovale, Inc. in South San Francisco, CA is seeking a Head of Quality and Regulatory to own the QMS and serve as the Management Representative.

This senior leadership role partners with Regulatory and Operations to drive compliant design, manufacturing, and post-market activities for the IntelliSep system and consumables. You will lead a cross-functional quality organization, set the quality strategy, oversee FDA QMSR, ISO 13485, and related standards, and ensure readiness for inspections.

Qualifications

• Bachelor's degree in engineering discipline.
• 10+ years of progressive quality leadership in medical devices.
• 7+ years managing quality teams and organizational performance.
• Experience leading FDA inspections and Notified Body audits.
• Deep working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, cGMP, and IVD regulatory requirements.
• Experience applying risk analysis, FMEA, and statistical methods.

Responsibilities

• Define and execute a company-wide Quality strategy aligned with regulatory obligations.
• Lead QA, QA Engineering, Design Quality, Quality Systems and audits.
• Own QMS; manage CAPA, change control, training and management review.
• Maintain FDA/ISO/QMSR compliance with proactive improvements.
• Lead FDA inspections and Notified Body audits; ensure inspection readiness.
• Drive design quality and regulatory roadmap with cross-functional partners.
• Develop and coach a high-performing quality team.
• Promote a company-wide culture of quality through hands-on leadership.

Skills

Quality leadership

FDA inspections

Notified Body audits

Process validation

Regulatory compliance

Quality systems

Education

Bachelor's degree in engineering

Tools

eQMS platforms

AI-enabled quality tools

Job description

Cytovale, Inc. in South San Francisco, CA is seeking a Head of Quality and Regulatory to own the QMS and serve as the Management Representative.

This senior leadership role partners with Regulatory and Operations to drive compliant design, manufacturing, and post-market activities for the IntelliSep system and consumables. You will lead a cross-functional quality organization, set the quality strategy, oversee FDA QMSR, ISO 13485, and related standards, and ensure readiness for inspections.