Director of Regulatory and Quality Assurance (Medtech)

TL;DR

Director of Regulatory and Quality Assurance (Medtech): Provides strategic leadership and operational oversight for regulatory affairs in at-home testing, IVDs, LDTs, and AI-enabled diagnostics with an accent on U.S. FDA requirements, CLIA accreditation, and quality management systems. Focus on developing enterprise regulatory strategies, managing submissions and inspections, and integrating regulatory-by-design into product lifecycles.

Hoffman Estates, IL or Austin, TX

$150,000 - $178,000

Company

Digital health company pioneering AI-powered biomarker intelligence, delivering personalized health insights through at-home testing, virtual care, and diagnostics.

What you will do

• Develop and maintain enterprise regulatory strategy for at-home testing ecosystem, IVDs, LDTs, and consumer wellness products aligned with business priorities.
• Anticipate FDA policy impacts, define go-to-market strategies, and advise leadership on regulatory risks and mitigations.
• Lead regulatory planning, documentation, submissions (510(k), De Novo), and interactions with FDA, CMS, CAP, and state bodies.
• Oversee quality management system, risk management, and post-market surveillance to support regulatory compliance.
• Embed regulatory and quality principles into product lifecycle with cross-functional teams and third-party providers.
• Build and mentor regulatory/quality team, fostering regulatory competencies organization-wide.

Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field; 7–10+ years in regulatory affairs for home diagnostics, IVDs, LDTs, or digital health.
• Expertise in FDA regulations for IVDs/LDTs/at-home kits, CLIA/CMS/NYS/CAP, 21 CFR Parts 820/11, ISO 13485/14971.
• Experience with regulatory submissions, agency interactions, audits/inspections, and managing physical/lab operations.
• Hands-on with software-driven products including AI/ML-enabled clinical decision support in diagnostics.
• Strong cross-functional communication and team leadership in fast-paced environments.

Nice to have

• RAC, ASQ, ISO 13485 Lead Auditor certification.
• Experience with eQMS systems like Greenlight Guru or MediaLab.
• Supporting health plan/B2B client regulatory obligations.
• Engagement with FDA on emerging LDTs, SaMD, AI/ML frameworks.

Culture & Benefits

• Annual bonus eligibility.
• Health, dental, vision, and mental health insurance.
• 401(k) with company match.
• Flexible PTO.
• Monthly $100 wellness stipend and various perks.