Senior VP, Quality & Regulatory

Blackhornvc; South San Francisco (CA); On-site; USD 230,000 - 360,000; Full time

Job summary

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

You will ensure FDA QMSR compliance, ISO standards, and regulatory readiness while shaping a robust quality engineering capability for the IntelliSep system and consumables. The role partners with Regulatory Affairs to chart an 18–24 month roadmap, leads audits, and elevates organizational quality culture through hands-on leadership across QA, QE,

Qualifications

• Bachelor's degree in engineering required.
• 10+ years of quality leadership in medical devices required.
• Experience leading QA/RA functions and FDA inspections.
• Deep knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and ISO 14971.
• Proven ability to lead cross-functional teams and drive improvement.

Responsibilities

• Define and execute an enterprise Quality strategy; establish objectives and KPIs for executive reporting.
• Lead Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, and audits.
• Own QMS and core processes: CAPA, nonconformance, deviation, complaint handling, change control, document control, training, management review.
• Drive process improvements to stay compliant while enabling rapid product iterations.
• Lead internal audits, post-market reviews, and inspection readiness for FDA and Notified Bodies.
• Direct design quality across development, allocate resources, and embed quality engineers in projects.
• Develop and maintain a 18–24 month regulatory roadmap covering 510(k)s, PCCPs, and related activities.
• Provide expertise in DOE, process validation, statistics, software validation, and risk management.

Skills

Quality leadership

Regulatory knowledge

Auditing

Risk management

Data analysis

Project management

Education

Bachelor's degree in engineering

MBA or Master’s in engineering/related field

Tools

eQMS platforms

AI-enabled quality tools

Job description

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

You will ensure FDA QMSR compliance, ISO standards, and regulatory readiness while shaping a robust quality engineering capability for the IntelliSep system and consumables. The role partners with Regulatory Affairs to chart an 18–24 month roadmap, leads audits, and elevates organizational quality culture through hands-on leadership across QA, QE,