Regulatory Affairs Specialist

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 to work directly with software engineers, ML engineers, and product managers. You can read a spec, ask the right questions, and write

requirements engineers will actually use. Demonstrated experience operationalizing compliance in a fast-moving environment: writing the SOP, running the training, collecting the evidence, and closing the audit finding. Strong written communication. You can draft an FDA submission section, a customer-facing security response, and an internal policy with equal clarity. Nice-to-haves Experience with dental imaging, radiology, or medical imaging more broadly. HIPAA program ownership at a covered entity or business associate, and direct experience leading a SOC 2 Type II audit. RAC certification or equivalent. Experience setting up a regulatory or compliance function from scratch at a Series A through C company. Familiarity with payments, RCM, or PHI-heavy workflows. What We Offer: Direct ownership of a critical function with a clear path to running compliance across Archy as we grow. A seat at the table on product and roadmap decisions. We treat compliance as a first-class input, not a checkbox at the end. Executive sponsorship from the CEO and active partnership with engineering and product leadership. The chance to shape how AI gets responsibly deployed inside dental practices nationwide. Competitive salary and equity (some roles may be eligible for performance-based incentives or bonuses) Health, dental, and vision insurance 401(k) plan Flexible vacation policy Remote-friendly culture

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