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). 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 🔗
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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.
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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.
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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.
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Run FDA Pre-Submissions — Draft Pre-Sub packages, prepare client teams for meetings, lead the FDA interaction, and translate feedback into next steps.
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Design clinical validation approaches — Standalone performance testing, MRMC reader studies, and equivalence analyses, working with our biostatisticians.
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Draft and own key regulatory deliverables — Software Descriptions, Clinical Validation Plans, Algorithm Change Protocols, PCCP documentation, and complete 510(k)/De Novo submission packages.
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Advise clients on FDA's AI/ML framework — Including Good Machine Learning Practice (GMLP), predetermined change control plans (PCCP), and real-world performance monitoring.
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Run client meetings, set agendas, and translate regulatory complexity into clear action items for both technical and executive audiences.
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Contribute to Innolitics thought leadership — Publish articles, open tools, and public datasets that advance the AI/ML SaMD ecosystem.
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Mentor junior regulatory staff on FDA processes and documentation quality.
What We're Looking For 🔗
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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. In the cover letter, briefly explain:
- Why this role interests you
- One FDA submission or regulatory strategy engagement where your AI/ML expertise made a difference
- 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.
