Head of Quality and Regulatory

Job overview

The Head of Quality and Regulatory role is onsite in South San Francisco, California. Compensation is described as competitive and commensurate with experience; numeric compensation is not specified. Cytovale is a medical diagnostics company whose IntelliSep test assesses sepsis risk using white blood cell structure. The role owns the company’s Quality Management System and leads quality functions supporting the IntelliSep system and consumables. It works closely with Regulatory Affairs to maintain compliance and plan product changes, while helping improvements reach customers predictably and compliantly.

What you'll do

• Set quality strategy and objectives
• lead Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and audits
• own QMS processes including CAPA, complaint handling, change control, and management review
• lead audits and inspection readiness
• partner on the regulatory roadmap
• direct design quality and supplier quality
• oversee post-market surveillance, investigations, and continuous improvement
• develop the quality team.

What we're looking for

Skills & competencies

head of quality and regulatory

quality management system

medical diagnostics

south san francisco ca

cytovale

intellisep

fda qmsr

iso 13485

quality assurance

regulatory compliance

post-market surveillance

Work arrangement

• Weekend coverage required

Why this role

Designated Management Representative accountable for QMS effectiveness and compliance under FDA QMSR, ISO 13485, ISO 14971, and applicable IEC standards.

About the employer

Cytovale is hiring for this role. Industry: All Other Miscellaneous Ambulatory Health Care Services. Sector: 62.