Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Location: Remote (U.S. only, excluding Alaska and Hawaii) Job Type: Full-time About Us Innolitics is a remote-first medical device consultancy that brings software engineering, AI/ML validation, cybersecurity, and regulatory affairs together on one team. Since 2012, we've helped 70+ medical devices reach market, including 50+ FDA clearances. Learn how we take devices from concept to clearance . About the Role We're hiring a Senior Regulatory Affairs Specialist to lead engagements across our full service portfolio for clients building AI/ML-enabled Software as a Medical Device (SaMD). This is not a documentation-only role. You'll shape how our clients think about their regulatory approach, advise on FDA's evolving AI/ML framework, and drive submissions to completion. You'll lead Fast 510(k) sprints, prepare BDD applications that unlock expedited FDA review, and run Pre-Sub meetings that set the strategic direction for an entire program. Recent client projects include: Coronary CT AI for plaque analysis and calcium scoring — two 510(k) clearances Chest CT radiology AI pursuing De Novo with MRMC reader studies Opportunistic screening algorithms using routine imaging data AI-powered diabetic retinopathy screening devices AI-powered dental diagnostic tools for caries and periodontal disease detection Automated neuroanatomy analysis in infant brain imaging Breast cancer pathology AI with predictive and prognostic claims AI-enabled digital stethoscope for heart and lung sound classification Pediatric imaging AI for a major children's research hospital This position is fully remote, with 2–3 trips per year, including client or conference travel and our annual company retreat. What You'll Do Lead Fast 510(k) engagements — Own the regulatory workstream in our sprint-based Fast 510(k) service, driving AI/ML SaMD submissions from kickoff to FDA submission in 3 months. Coordinate with engineering to ensure software lifecycle documentation (IEC 62304), risk management (ISO 14971), and cybersecurity deliverables stay on track. Develop regulatory strategies — Conduct pathway assessments (510(k), De Novo, PMA), intended use scoping, predicate analysis, and clinical study design. Deliver clear, actionable regulatory strategy reports that become the roadmap for the entire engagement. Prepare and submit Breakthrough Device Designation (BDD) applications — Evaluate devices against FDA's BDD criteria, build the unmet-need and clinical-benefit arguments, and, for eligible engagements, submit applications on guaranteed timelines. Run FDA Pre-Submissions — Draft Pre-Sub packages, prepare client teams for meetings, lead the FDA interaction, and translate feedback into next steps. Draft and own key regulatory deliverables — Software Descriptions, Clinical Validation Plans, Algorithm Change Protocols, PCCP documentation, and complete 510(k)/De Novo submission packages. Advise clients on FDA's AI/ML framework — Including Good Machine Learning Practice (GMLP), predetermined change control plans (PCCP), and real-world performance monitoring. Run client meetings , set agendas, and translate regulatory complexity into clear action items for both technical and executive audiences. Mentor junior regulatory staff on FDA processes and documentation quality. What We're Looking For 5+ years of experience in FDA regulatory affairs for medical devices, with direct involvement in SaMD submissions, is a firm requirement. Demonstrated experience taking at least one SaMD through an FDA clearance or approval (510(k), De Novo, or PMA). Demonstrated experience taking at least one AI/ML device through an FDA clearance or approval (510(k), De Novo, or PMA) is a strong plus. Familiarity with FDA's AI/ML guidance, PCCP framework, and relevant standards (IEC 62304, ISO 14971, IEC 82304). Strong understanding of clinical validation design for AI/ML devices. Excellent regulatory writing — clear, precise, and structured for FDA reviewers. Ability to lead client engagements independently and communicate regulatory strategy to both technical and executive audiences. Comfortable reading and interpreting FDA guidance, predicate device summaries, and clinical literature. Experience with Breakthrough Device Designation applications is a strong plus. Familiarity with software development practices and ML pipelines is strongly preferred. You don't need to write code, but you need to understand how software architecture decisions affect the regulatory strategy. RAC certification or advanced degree in a relevant field (biomedical engineering, regulatory science, etc.) is a plus but not required. Former FDA experience is a bonus, but not required. Hands-on experience implementing ISO 13485 and FDA-compliant Quality Management Systems is beneficial, but not required. What We Offer Competitive base salary ($120,000 – $160,000) depending on experience and modifiers such as: FDA experience, post-bachelors education, and number of FDA submissions completed. Significant additional compensation available for experience at CDRH and/or CBER. 12% performance-based bonus Fully remote work with flexible hours Comprehensive PTO package Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan Annual company retreat for team building and collaboration Opportunity to shape Innolitics' AI/ML regulatory practice and build a public reputation in the space Work directly with company leadership on high-impact engagements #J-18808-Ljbffr Innolitics LLC