IVD GMP Documentation Scientist — Regulatory & QC Lead

Delfidiagnostics; Palo Alto (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

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.

Qualifications

• Experience authoring GMP documentation: BMRs, CoAs, study plans, manufacturing reports, SOPs, and process validation packages.
• Direct experience contributing to FDA PMA, 510(k), or BLA/NDA submission packages — specifically manufacturing sections.
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and design control requirements.

Responsibilities

• Author and revise reagent manufacturing and qualification procedures to meet GMP/IVD documentation requirements (21 CFR 820, ISO 13485).
• Develop batch record templates and finalize BMRs for GMP reagent manufacturing processes.
• Create CoAs and specification documents for GMP-grade reagents and materials.
• Draft and maintain manufacturing study plans and summary reports for lot qualification and process characterization.
• Revise SOPs and DHR/DMR content; support PMA submission documentation.
• Compile manufacturing evidence for regulatory submissions and maintain DHF documentation packages.
• Review CMO documentation for GMP compliance prior to lot release and support incoming QC workflows.

Skills

GMP documentation

Batch records

CoAs

Study plans

SOPs

DHR/DMR

FDA PMA/510(k)

21 CFR 820

ISO 13485

eQMS control

CMO oversight

Process validation

Education

BS in GMP manufacturing/tech transfer

MS in GMP manufacturing/tech transfer

PhD in GMP manufacturing/tech transfer

Tools

NetSuite

Job description

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.