Senior Director, Quality & Regulatory Compliance

Posted 2 days ago

cytovaleSouth San Francisco (CA)

Regulatory Affairs Managers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

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.

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