Regulatory Affairs Specialist

About This Role

A Regulatory Affairs Specialist is needed to own FDA compliance for Archy's dental software products, lead the regulatory strategy for new products, and expand into company-wide compliance. This high-ownership role offers executive visibility and suits someone with experience in 510(k) lifecycle for SaMD or AI/ML-enabled medical devices.

Responsibilities

• Own the lifecycle of Archy Imaging's existing 510(k) clearance, including change assessments, Special and Traditional 510(k) submissions, predicate analysis, and substantial equivalence arguments
• Own and maintain the Quality Management System
• Run the post-market program for Archy Imaging, including complaint handling, MDR reporting, post-market surveillance, labeling reviews, and future FDA correspondence
• Maintain and evolve the software development lifecycle to meet IEC 62304, ISO 14971, and FDA expectations for SaMD and AI/ML-enabled device software, including designing and maintaining the Predetermined Change Control Plan
• Lead the regulatory strategy for new Archy products and features, deciding classification, intended use boundaries, and the appropriate regulatory pathway
• Partner with engineering and product to integrate regulatory requirements into the development process, reviewing 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 roadmap actions
• Own HIPAA compliance, including BAAs, policies, workforce training, risk assessments, breach response, and audit response
• Lead the SOC 2 program (currently Type II), including auditor management, control design, evidence collection, and remediation, evolving its scope as products and customer segments are added
• Build a lightweight, scalable compliance program for a fast-moving SaaS company, with clear policies, automated evidence, and crisp answers to customer security questionnaires
• Serve as the internal expert on regulatory and compliance implications of new products, partners, and data flows

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, including at least one submission and ideally several change assessments and follow-on filings
• Strong working command of relevant standards and frameworks 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, reading specs, asking the right questions, and writing usable requirements