Regulatory Affairs Specialist

About Archy Smile! Those teeth you are showing deserve the best care you can give them, yet the status quo of the software your dentist uses today is outdated. Archy is a Series B vertical SaaS solution revolutionizing the dental practice management space — giving dental providers AI agents and software that lets them do what they do best (be dentists!) while we handle the more technical sides of running their practice business. Our product portfolio includes Archy Imaging (FDA 510(k) cleared dental imaging software), Archy Scribe, and Archy Revenue. As we expand what these products do inside the operatory, the regulatory surface area grows with us. We need someone who can own that work end to end. Job Description: We are hiring a dedicated Regulatory Affairs Specialist to own FDA compliance for Archy, lead the regulatory strategy for adjacent products as they mature, and grow into owning company-wide compliance (HIPAA, SOC 2, and what comes next). This is a high-ownership role with executive visibility from day one. If you have lived inside the 510(k) lifecycle for SaMD or AI/ML-enabled medical devices and want to build a compliance function from the ground up rather than inherit one, this is the role. Job Responsibilities: FDA and SaMD compliance (primary focus) - Own the lifecycle of Archy Imaging's existing 510(k) clearance: change assessments (letter-to-file vs. new 510(k)), Special and Traditional 510(k) submissions for new features and indications, predicate analysis, and substantial equivalence arguments. - Own and maintain our Quality Management System. - Run the post-market program for Archy Imaging: complaint handling, MDR reporting, post-market surveillance, labeling reviews, and any future FDA correspondence including pre-submissions and inspection readiness. - Maintain and evolve our software development lifecycle so it cleanly meets IEC 62304, ISO 14971, and FDA's expectations for SaMD and AI/ML-enabled device software. Where AI/ML is in scope, design and maintain the Predetermined Change Control Plan. - Lead the regulatory strategy for new Archy products and features as they approach regulated territory. For each product, decide classification, intended use boundaries, and the right pathway (510(k), De Novo, exempt, or not a device). - Partner with engineering and product to bake regulatory requirements into how we build, not bolt them on at the end. Review feature specs, design history file content, V&V protocols, risk files, and release artifacts. - Track FDA guidance on AI/ML, clinical decision support, dental imaging, and SaMD, and translate changes into concrete actions for our roadmap. Broader compliance ownership (growth scope) - Own HIPAA compliance: BAAs, policies, workforce training, risk assessments, breach response, and audit response. - Lead our SOC 2 program (currently Type II) including auditor management, control design, evidence collection, and remediation. Evolve scope as we add products and customer segments. - Build a lightweight, scalable compliance program that fits a fast-moving SaaS company: clear policies, automated evidence where possible, and crisp answers to customer security questionnaires. - Serve as the internal expert on the regulatory and compliance implications of new products, new partners, and new data flows (for example, radiologic AI integrations, payments, and clinical AI features). Job Requirements: Must-haves - 5+ years in regulatory affairs at a medical device, digital health, or healthcare SaaS company, with hands-on experience across the full 510(k) lifecycle for SaMD or AI/ML-enabled software. You have lived through at least one submission and ideally several change assessments and follow-on filings. - Strong working command of the standards and frameworks that matter for SaMD: 21 CFR Part 820 / QMSR, IEC 62304, ISO 14971, ISO 13485 fundamentals, FDA SaMD and AI/ML guidance, premarket cybersecurity expectations (including SBOM), and labeling requirements. - Ability t