Director of Regulatory and Quality Assurance

Everlywell•Hoffman Estates, IL

13d•$150,000 - $178,000

About The Position

Everlywell is a digital health company pioneering the next generation of biomarker intelligenceâcombining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insightsâseamlessly 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 weâre just getting started. Fueled by AI and built for scale, weâre 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 Healthâs 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

Requirements

Bachelor's degree in Life Sciences,Regulatory Affairs, or related field (advanced degree a plus)
Minimum 7-10 years of experience in regulatory affairs and/or quality assurance within diagnostics, medical devices, or digital health sectors.
Expertise in 21 CFR Part 820, ISO 13485, 14971, and 62304
Expertise in FDA regulatory submissions (510(k), Convenience Kit, EUA, etc.)
Expertise in CLIA and NYS accreditation requirements
Experience in managing regulatory and quality oversight for both physical product manufacturing and moderate complexity laboratory.
Proven success leading audits/inspections and responding to agency inquiries.
Exceptional cross-functional communication and influencing skills.
Demonstrated success managing and mentoring high-performing teams.
Hands-on experience with software-driven healthcare products (e.g., SaMD, clinical decision support tools, digital health platforms) and their associated regulatory and quality requirements.

Nice To Haves

ASQ or ISO 13485 Lead Auditor certification.
Experience with eQMS systems (e.g., Greenlight Guru and/or MediaLab).
Experience supporting health plan or B2B client regulatory and quality obligations.
Strong understanding of software validation and cloud-based quality systems.
Experience leading or participating in AI governance or clinical decision-making committees in a healthcare, diagnostics, or digital health setting.
Familiarity with industry best practices and emerging standards for responsible AI in healthcare (e.g., transparency, bias mitigation, human oversight, and documentation expectations).

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.
Develop and lead regulatory strategy for AI- and ML-enabled diagnostic features and clinical decision support tools (e.g., risk scores, triage logic, interpretive reports), ensuring alignment with applicable FDA CDS and SaMD expectations and other emerging AI regulations.
Serve as a liaison with regulatory bodies and support audit/inspection readiness and responses.
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.
Define and oversee quality and risk controls for software and AI systems, including requirements, verification/validation (V&V), change control, and lifecycle documentation for SaMD and AI/ML models.
Partner with Product, Technology, Legal, and Operations to embed regulatory and quality by design principles early in the product lifecycle, including requirements for SaMD under IEC 62304 and CLIA/NYS validation standards.
Collaborate with Engineering and Manufacturing teams to ensure digital and physical product quality standards are met and sustained.
Guide quality oversight for third-party service providers, including contract manufacturers, labs, and fulfillment partners.
Partner closely with Data Science, Clinical, and CX teams to design and validate AI-enabled features and clinical decision support logic used in patient journeys and provider experiences as well as ensure that clinical decision pathways (e.g., triage rules, escalation thresholds, interpretive content) are evidence-based, documented, and governed through change control and clinical review.
Lead, coach, and mentor a team of regulatory and quality professionals.
Foster a high-performing, inclusive, and psychologically safe team environment.
Develop capabilities on the team related to AI, data-driven quality management, and clinical decision support, including training, playbooks, and standard work.