Director of Regulatory and Quality Assurance (Hoffman Estates, IL or Austin, TX)
7 days ago
Austin
Job Description 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 expectationsResponsibilities: Regulatory Strategy (Strategic) Develop and maintain an enterprise regulatory strategy for Everlywell’s at-home testing ecosystem, including IVDs, LDTs, and consumer wellness products, ensuring alignment with business priorities and product roadmaps. * Anticipate and assess the impact of evolving FDA policies and guidance (e.g., at-home testing, Convenience Kits, LDT framework changes, enforcement discretion, AI/ML in SaMD) on Everlywell’s offerings and operations; translate these into clear strategic recommendations for senior leadership. * Define regulatory go-to-market and lifecycle strategies for new and existing products (e.g., selection of IVD vs. LDT pathways, use of enforcement discretion, labeling/positioning of wellness vs. diagnostic claims). * Serve as a trusted advisor to executive leadership on regulatory risk/benefit tradeoffs and mitigation strategies, including scenario planning for new or proposed regulations impacting at-home diagnostics and digital health. Responsibilities - Regulatory Affairs – At-Home Testing, IVD, LDT, and AI (Operational) * Interpret and apply complex and evolving U.S. regulations and guidance impacting: * At-home specimen collection and test kits * IVDs and LDTs * Consumer wellness and “health insight” products * Lead end-to-end regulatory planning and documentation for new products and product changes, including: * Regulatory assessments and classification/risk analyses * Labeling, IFU, and marketing claims reviews to ensure they are compliant with IVD/LDT/wellness positioning * Design, validation, and change documentation for IVD and LDT offerings * Oversee the preparation, submission, and maintenance of regulatory filings and registrations, including (as applicable): * FDA premarket submissions (e.g., 510(k), De Novo, Convenience Kit proposals) and amendments * CLIA/CMS, NYS, CAP, and other laboratory accreditations and renewals * Device listings, establishment registrations, state-level filings, and other required notifications. * Serve as primary regulatory liaison with FDA, CMS, CAP, NYS, and other regulatory and accrediting bodies, including: * Managing interactions, meetings, and correspondence * Ensuring Everlywell is inspection-ready at all times * Leading responses to inquiries, inspections, and enforcement actions, if any. * Establish and maintain regulatory intelligence processes to monitor and disseminate key changes in laws, regulations, standards, and guidances impacting at-home testing, IVDs, LDTs, and AI/ML-enabled diagnostics. Responsibilities: Regulatory Operations and Governance (Operational) * Build and manage regulatory operations processes and infrastructure (e.g., templates, trackers, systems) that enable efficient and consistent regulatory documentation, submissions, and ongoing maintenance. * Implement and oversee a regulatory change control framework that: * Evaluates regulatory impact of product, labeling, supplier, or process changes * Ensures appropriate internal review and approvals prior to implementation * Maintains clear traceability between design, validation, and regulatory status. * Collaborate with Legal and Compliance to integrate regulatory requirements into enterprise governance Responsibilities: Quality Management and Risk (Strategic & Operational – Supporting Regulatory) * Provide strategic oversight of the Quality Management System (QMS) to ensure it effectively supports regulatory obligations under FDA QSR, ISO 13485, CLIA, and client requirements. * Ensure that design control, risk management, and post-market surveillance activities are aligned with regulatory requirements for IVDs and LDTs (e.g., ISO 14971 hazard analysis, risk controls, and residual risk acceptability). * Oversee enterprise-level risk management processes (e.g., hazard analysis, FMEA, CAPA) such that regulatory risks are identified, documented, escalated, and mitigated. * Serve as Management Representative for regulatory inspections, internal audits, and customer audits, ensuring that QMS elements critical to regulatory compliance are robust and well-documented. Responsibilities - Cross-Functional Leadership and Product Lifecycle Integration (Strategic & Operational) * Partner with Product, Technology, Clinical, and Operations teams to embed regulatory-by-design and quality-by-design principles early in the product lifecycle for at-home tests, IVDs, LDTs, and AI-enabled features. * Collaborate with Engineering, Manufacturing, and Laboratory Operations to ensure that: * Kit design, packaging, labeling, and instructions support compliant at-home use. * Lab processes for LDTs and IVDs meet regulatory requirements, including method validation, stability, and performance monitoring. * Provide regulatory input into product requirements, UX flows, and clinical content for AI/ML and clinical decision support tools, ensuring traceability from intended use to validation and labeling. * Guide oversight for third-party service providers (e.g., contract manufacturers, labs, fulfillment partners) to ensure that regulatory and quality expectations are contractually defined, monitored, and met. Responsibilities: Talent, Culture, and Capability Building * Lead, coach, and mentor a high-performing regulatory and quality team, with emphasis on: * Deep expertise in at-home testing, IVDs, LDTs, and digital health regulation * Strong collaboration and communication skills with technical and non-technical stakeholders. * Foster an inclusive, learning-oriented culture that proactively surfaces regulatory risks and encourages early engagement with the Regulatory function. * Develop and maintain regulatory competencies across the organization related to: * At-home diagnostic regulation * LDT vs. IVD frameworks * AI/ML, SaMD, and CDS expectations * Data-driven quality and post-market monitoring. Required Qualifications * Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field; advanced degree (e.g., MS, PhD, PharmD, JD) is a plus. * 7–10+ years of experience in regulatory affairs within home diagnostics, medical devices, in vitro diagnostics, or digital health, with direct responsibility for at-home testing, IVDs, and/or LDTs. * Demonstrated expertise in: * FDA regulations and guidance for IVDs, LDTs, at-home collection kits, and related enforcement discretion policies. * Clinical laboratory regulation and accreditation (CLIA, CMS, NYS, CAP). * 21 CFR Part 820, 21 CFR Part 11, and ISO 13485/14971 as they relate to regulatory expectations for IVDs and LDTs. * Regulatory submissions and filings (e.g., 510(k), De Novo, Convenience Kit proposals, notifications, and related correspondence). * Experience managing regulatory oversight for both physical product manufacturing and moderate complexity laboratory operations. * Proven success leading agency and accreditor interactions, audits/inspections, and responses. * Hands-on experience with software-driven healthcare products, including clinical decision support tools, SaMD, and/or AI/ML-enabled features, preferably in the context of diagnostics or at-home testing. * Exceptional cross-functional communication, influence, and stakeholder management skills, including the ability to explain complex regulatory concepts to non-experts. * Demonstrated success managing and mentoring regulatory or quality teams in a fast-paced, high-growth environment. Preferred Qualifications: * RAC, ASQ, ISO 13485 Lead Auditor, or similar professional certification. * Experience implementing or using eQMS systems (e.g., Greenlight Guru, MediaLab) to support regulatory and quality workflows. * Experience supporting health plan or B2B client regulatory and quality obligations related to diagnostics or digital health products. * Prior experience engaging with FDA or other regulators on emerging regulatory frameworks for LDTs, SaMD, and AI/ML-enabled diagnostics is highly desirable. This salary range for this position is $150,000 - $178,000 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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