Clinical Lab QA & Regulatory Architect

SeqMatic LLC.; Fremont (CA); On-site; USD 125,000 - 145,000; Full time

Job summary

SeqMatic LLC. in Fremont, CA seeks a Clinical Laboratory QA & Regulatory Specialist to architect and scale the quality and regulatory framework for new NGS-based LDTs.

This full-time, in-house role blends hands-on execution with strategy and requires owning the compliance program from the ground up. The candidate will lead CLIA/CAP registrations, develop validation packages, and implement a lean QMS while collaborating with bioinformatics and LIMS teams.

Qualifications

• Education: degree in a life-science field with regulatory exposure.
• Experience: 3+ years in regulatory affairs, QA, or high-complexity CLIA/CAP labs.
• Technical domain: NGS workflows, data integrity standards, ACMG/AMP variant interpretation.
• LDT acumen: familiarity with CLIA, CAP, California lab laws, FDA Final Rule on LDTs.
• Startup mentality: ability to build processes from scratch and author SOPs.
• Communication: strong technical writing and cross-functional coordination.

Responsibilities

• Establish Compliance Infrastructure: secure CLIA, CAP, and California licenses from the ground up.
• Author and organize validation packages for high-complexity NGS assays per CLIA/CAP guidance.
• Interpret FDA LDT frameworks and manage adverse event reporting and corrective actions.
• Design and maintain a lean, scalable Quality Management System (QMS) and SOPs.
• Collaborate with bioinformatics and LIMS teams to document pipelines and data integrity controls.
• Serve as technical lead for external audits and state inspections.

Skills

Regulatory affairs

Quality assurance

LDT knowledge

Scientific writing

Startup mindset

Project management

Education

Bachelor's degree in Molecular Biology

Master's degree in Bioinformatics

Job description

SeqMatic LLC. in Fremont, CA seeks a Clinical Laboratory QA & Regulatory Specialist to architect and scale the quality and regulatory framework for new NGS-based LDTs.

This full-time, in-house role blends hands-on execution with strategy and requires owning the compliance program from the ground up. The candidate will lead CLIA/CAP registrations, develop validation packages, and implement a lean QMS while collaborating with bioinformatics and LIMS teams.