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 oversight of Everly Health’s enterprise Quality Management System (QMS) and regulatory affairs operations. This role is accountable for ensuring quality and regulatory compliance across Everly Health's FDA-regulated manufacturing operations, CLIA-certified moderate complexity laboratory, and other lines of business. This position works cross-functionally with internal stakeholders and external partners to support enterprise-wide compliance with applicable U.S. and global regulatory frameworks, including:
21 CFR Part 820 (QSR)
ISO 13485
ISO 14971
21 CFR Part 11 (Electronic Records and Signatures)
FDA and CMS guidelines
FDA and state-level guidance on labeling, test kits, and software as a medical device (SaMD)
CLIA/NYS/CAP regulations
Regulatory Affairs Responsibilities:Lead the preparation and submission of regulatory filings (e.g., FDA, NYS, CMS, CAP), including premarket notifications, amendments, and renewals.Interpret and apply complex and evolving U.S. regulations and guidance impacting IVDs, SaMD, telehealth, and consumer wellness products.Advise executive leadership on regulatory strategy, including changes affecting at-home diagnostics, software development, and kit configuration under FDA's Convenience Kit guidance and enforcement discretion.Serve as a liaison with regulatory bodies and support audit/inspection readiness and responses.Quality Assurance and Compliance Responsibilities:Develop, lead, and continuously improve the enterprise Quality Management System to ensure compliance with QSR, ISO 13485, and applicable client-imposed compliance frameworks.Serve as Management Representative for regulatory inspections, internal audits, and customer audits.Oversee enterprise-level risk management processes, including hazard analysis, FMEA, and CAPA systems.Establish and monitor key quality and compliance KPIs; use data-driven insights to inform risk mitigation and continuous improvement initiatives.This salary range for this position is $160,000 - $190,000 based on the selected candidate's qualifications, market data/ranges, location, and internal equity. This position is also eligible for an annual bonus, health, dental, vision & mental health insurance, 401(k) with company match, Flexible PTO, a monthly $100 wellness stipend and various other perks.
