Director of Regulatory and Quality Assurance (Hoffman Estates, IL or Austin, TX)

Develop and maintain an enterprise regulatory strategy for Everlywells 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 Everlywells 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.

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

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.

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.

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.

Bachelors degree in Life Sciences Regulatory Affairs or a related field; advanced degree (e.g. MS PhD PharmD JD) is a plus.

710 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.

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.