Frontier Tech Fda Regulation Jobs

…as the primary interface with FDA

You think about regulation from first principles.

…a CLIA/CAP lab, or with FDA 21 CFR Part 11.

Deep knowledge of global GMP regulations and guidance, including 21 CFR Parts 210 and 211, EU GMP/EudraLex Volume 4, relevant

…11, or cybersecurity guidance ( FDA, IEC 81001-5-1).

…blood sample, processed by a regulated laboratory.

/ML in regulated environments and can reason about where the expectations are heading.

…regulatory rigor (ISO 13485, IVDR, FDA environments).

With the FDA Modernization Act 3.0 and the FDA's March 2026 validation framework, the regulatory tailwinds only continue to get stronger.

…processes meet CLIA/CAP, HIPAA, and FDA

…this opportunity: Freenome is approaching FDA approval and commercial launch of SimpleScreen™, our

Responsibilities Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs.

…17025 lab practices, ISO 13485, FDA 21 CFR 820, or comparable regulated-environment quality systems.

…product development lifecycle in a regulated environment.