Director of Regulatory and Quality Assurance

Director Of Regulatory And Quality Assurance

Everlywell is a digital health company pioneering the next generation of biomarker intelligencecombining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insightsseamlessly 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 :

Quality Assurance And Compliance Responsibilities :

Cross-functional Leadership And Strategy Responsibilities :

Talent And Culture Responsibilities :

Required Qualifications :

Preferred Qualifications :

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.