Regulatory Affairs Specialist

Archy

50d • $100,000 - $150,000 • Remote

About The Position

Archy is a Series B vertical SaaS solution revolutionizing the dental practice management space. 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.

Requirements

• 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.

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).

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed