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.

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.