Regulatory Affairs Specialist

About reputed company Smile! Those teeth you are showing deserve the reputed company you can give them, yet the status reputed company of the software your dentist uses today is outdated. reputed company is a Series B vertical SaaS solution revolutionizing the dental practice management reputed company — 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 reputed company Imaging (FDA 510(k) cleared dental imaging software), reputed company reputed company, and reputed company reputed company. 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 reputed company, reputed company 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 reputed company 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 reputed company Imaging: complaint handling, MDR reporting, post-market surveillance, labeling reviews, and any future FDA correspondence including pre-submissions and inspection readiness. Maintain and reputed company 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. reputed company the regulatory strategy for new reputed company products and features as they approach regulated territory. For each product, decide classification, intended use boundaries, and the right pathway (510(k), reputed company, exempt, or not a device). Partner with engineering and product to bake regulatory requirements into how we build, not reputed company 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. reputed company our SOC 2 program (currently Type II) including auditor management, control design, evidence collection, and remediation. reputed company 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 reputed company answers to customer reputed company 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 reputed company features). Job Requirements: Must-haves 5+ years in regulatory affairs at a medical device, digital health, or reputed company 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 reputed company 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 reputed company, a customer-facing reputed company response, and an internal policy with equal reputed company. reputed company-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. reputed company Offer: Direct ownership of a critical function with a clear path to running compliance across reputed company as we grow. A seat at the table on product and roadmap reputed company. 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 reputed company. Competitive salary and equity (some roles may be eligible for performance-based incentives or bonuses) Health, dental, and reputed company insurance 401(k) plan Flexible vacation policy Remote-friendly culture Apply To This Job