Director of Regulatory and Quality Assurance
Director of Regulatory and Quality Assurance
Posted on :
28-08-2025
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1 Vacancy
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Monthly Salary
$ 160000 - 190000
Vacancy
1 Vacancy
Posted on :
28-08-2025
Job Description
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 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 were just getting started. Fueled by AI and built for scale were 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 Healths enterprise Quality Management System (QMS) and regulatory affairs operations. This role is accountable for ensuring quality and regulatory compliance across Everly Healths 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:
- 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 FDAs Convenience Kit guidance and enforcement discretion.
- Serve as a liaison with regulatory bodies and support audit/inspection readiness and responses.
Quality Assurance and Compliance Responsibilities:
- 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 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.
Cross-functional Leadership and Strategy Responsibilities:
- 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.
Talent and Culture Responsibilities:
- Lead coach and mentor a team of regulatory and quality professionals.
- Foster a high-performing inclusive and psychologically safe team environment.
Required Qualifications:
- Bachelors degree in Life SciencesRegulatory 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 and 62304
- Expertise in FDA regulatory submissions (510(k) Convenience Kit EUA etc.)
- Expertise in Risk management tools (FMEA fault tree root cause analysis etc.)
- 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
Preferred Qualifications:
- Knowledge of CLIA and NYS accreditation requirements and quality management systems
- ASQ or ISO 13485 Lead Auditor certification
- Experience with eQMS systems (ie: 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
This salary range for this position is $160000 - $190000 based on the selected candidates 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.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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