Fda Regulation Jobs in United States

…customers on regulatory requirements across FDA, EMA, and other relevant jurisdictions as they apply to AI-enabled

Experience working at the FDA or directly interfacing extensively with FDA. Strong experience with FDA regulations and regulatory landscape.

…as the primary interface with FDA

…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

…data validation, regulatory posture ( FDA

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

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

…blood sample, processed by a regulated laboratory.

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

…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.

Monitor emerging laws and regulations affecting Abridge’s products and data practices and advise internal stakeholders on their implications.

…Firm understanding of cGMP and FDA