Director of Regulatory and Quality Assurance (Hoffman Estates, IL or Austin, TX)

Everlywell is a digital health company pioneering the next generation of biomarker intelligence—combining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insights—seamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens.

Over the past decade, Everlywell has delivered close to 1 billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. In 2024 alone, an estimated 1 in 86 U.S. households received an Everlywell test, solidifying our spot as the #1 at-home testing brand in the country. And we’re just getting started. Fueled by AI and built for scale, we’re breaking down barriers, closing care gaps, and unlocking a more connected healthcare experience that is smarter, faster, and more personalized.

The Director of Regulatory and Quality Assurance provides strategic leadership and hands-on operational oversight for Everlywell’s regulatory affairs program, with primary emphasis on U.S. regulatory requirements for at-home testing, IVDs, LDTs, and related digital/AI-enabled diagnostic solutions. The role is responsible for interpreting, operationalizing, and continuously monitoring complex and evolving regulatory frameworks that impact Everlywell’s product portfolio, including test kits, laboratory-developed tests, in vitro diagnostics, and consumer wellness offerings.

While this role also oversees Everlywell’s Quality Management System (QMS), the priority focus is regulatory strategy and execution, ensuring that quality systems, risk management, and operational processes support and enable compliant regulatory pathways.

The Director works cross-functionally with Product, Technology, Clinical, Legal, Operations, Data Science, and Commercial teams, as well as external partners, to ensure enterprise-wide compliance with applicable U.S. regulatory frameworks, including, but not limited to:

• FDA requirements and guidance governing:
  • At-home specimen collection and test kits (including Convenience Kits and enforcement discretion policies)
  • IVDs and LDTs
  • Clinical decision support (CDS), including AI/ML-enabled features
• CLIA, CMS, and state requirements (e.g., NYS, CAP accreditation) for moderate complexity laboratories)
• 21 CFR Part 820 (QSR) and 21 CFR Part 11
• ISO 13485, ISO 14971, and related risk management expectations