--- title: 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](https://innolitics.com/services/end-to-end-fda-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). You\'ll own the regulatory pathway from intended use scoping and submission strategy through clinical validation planning and FDA interactions. 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. - **Design clinical validation approaches** --- Standalone performance testing, MRMC reader studies, and equivalence analyses, working with our biostatisticians. - **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. - **Contribute to Innolitics thought leadership** --- Publish [articles, open tools, and public datasets](https://innolitics.com/articles/) that advance the AI/ML SaMD ecosystem. - **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 AI/ML SaMD submissions. - Demonstrated experience taking at least one AI/ML device through an FDA clearance or approval (510(k), De Novo, or PMA). Experience with Breakthrough Device Designation applications is a strong plus. - Deep 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. - 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 - 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 ### How to Apply Please fill out [this application form](https://app.notion.com/p/348bd5b7a75480b7a354e6993f06a68d). In the cover letter, briefly explain: 1. Why this role interests you 2. One FDA submission or regulatory strategy engagement where your AI/ML expertise made a difference 3. How you stay current with FDA\'s evolving AI/ML framework and guidance ### What Happens Next We\'ll review your application and contact strong matches. The process includes interviews, a short take-home exercise, and two reference checks. ### [Apply Today →](https://app.notion.com/p/348bd5b7a75480b7a354e6993f06a68d)