IVD GMP Documentation Scientist — Regulatory & QC Lead
Delfidiagnostics
DELFI Diagnostics, Inc. is seeking an experienced scientist to own GMP reagent manufacturing documentation under ISO 13485 for high-risk IVD devices. You will craft procedures, templates and records such as BMRs, CoAs, and DHF content, coordinating with assay development, regulatory and quality teams. You will author and revise GMP documentation, batch records, CoAs and study plans, ensuring regulatory compliance and fitness for PMA submissions. Hybrid workdays are offered near Palo Alto. #J-18808-Ljbffr Delfidiagnostics
Vacancy posted 3 days ago
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