Head of Quality and Regulatory

Cytovale, Inc. | South San Francisco, CA

Reports to: Chief Operating Officer

Level: Senior Director / Vice President, commensurate with experience

Function: Quality and Regulatory Compliance

Location:
Bay area, onsite role

Cytovale is a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovale's Intelli Sep test is the first and only stand-alone sepsis detection assay to quickly and accurately analyze white blood cell structure to stratify a patient's risk of sepsis. The test simply and clearly shows risk of sepsis using a biomechanical evaluation of white blood cells from a standard blood draw, generating results in less than 10 minutes.

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The Head of Quality and Regulatory owns Cytovale's Quality Management System and serves as the company's designated Management Representative. This leader is accountable for the effectiveness and compliance of the QMS under FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable IEC standards, and for the quality engineering capability that supports design change, process validation, and on-market product improvement for the Intelli Sep system and its consumables.

The role is quality-first with a strong regulatory partnership. Working alongside the Senior Director of Regulatory Affairs, the Head of Quality and Regulatory shapes an 18- to 24-month regulatory roadmap spanning letters to file, Special and Traditional 510(k) s, and Predetermined Change Control Plans (PCCPs), so that product and reliability improvements reach customers predictably and compliantly. The position leads all internal and external audits, third-party registrations, and agency inspections, and is expected to make the organization both more compliant and more nimble.

• Define and execute an enterprise Quality strategy that supports regulatory obligations, operational objectives, and long-term growth; establish annual quality objectives and the KPIs used to report progress to executive leadership.
• Lead a multidisciplinary Quality organization spanning Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and the audit program.
• Set the strategy for quality infrastructure, including eQMS evolution and the application of AI and analytics to quality processes.

• Serve as Management Representative; own the effectiveness of the QMS and its core processes, including CAPA, nonconformance and deviation management, complaint handling, change control, document control, training, and management review.
• Drive process improvements that allow the organization to move quickly while maintaining full FDA, ISO, and QMSR compliance, with documentation that is cohesive, consistent, and built on continuous-improvement principles.
• Establish and sustain a disciplined operating rhythm for internal audits, annual post-market reviews, and periodic management reviews.
• Maintain a proactive state of inspection readiness and lead the organization through FDA inspections, Notified Body audits, and third-party registration activities.

• Direct design quality assurance across product development and design-change programs, allocating resources, managing budgets, and embedding quality engineers in project teams to ensure efficient, compliant execution.
• Partner with the Senior Director of Regulatory Affairs to develop and maintain a forward-looking 18- to 24-month regulatory roadmap covering letters to file, Special and Traditional 510(k) s,…