Senior Regulatory Affairs Specialist AI/ML SaMD

Location: Remote (U.S. only)

Job Type: Full-time

About Us 🔗

Innolitics LLC is a remote-first professional services firm specializing in medical device software development, FDA regulatory consulting, and cybersecurity. Since 2012, we've helped 70+ medical devices reach market — including 50+ FDA clearances — through our integrated service lines:

  • Fast 510(k) — Our flagship offering. An accelerated, sprint-based offering for AI/ML SaMD teams seeking a 510(k) submission on an aggressive timeline. We guarantee AI/ML SaMD 510(k) submission by combining software engineering, regulatory expertise, and our MedTech OS platform.
  • Regulatory Strategy & Pre-Submission — We define the regulatory path of least resistance: pathway selection, intended use scoping, predicate analysis, clinical study design, and FDA Pre-Sub preparation and execution.
  • Breakthrough Device Designation (BDD) — We prepare and submit guaranteed BDD applications for devices targeting life-threatening or irreversibly debilitating conditions, unlocking expedited FDA review and investor confidence.
  • Guided 510(k) — For teams that want to own the documentation process, we provide templates, review, and expert guidance at every sprint.
  • Cybersecurity & Compliance — Full cybersecurity documentation packages including threat modeling, SBOM, penetration testing coordination, and FDA eSTAR compliance.

We are a small, high-caliber team that values clear thinking, intellectual honesty, and deep domain expertise. We combine regulatory strategy with strong technical fluency to help clients navigate both product development and FDA submission requirements.

About the Role 🔗

We're hiring a Senior AI/ML Regulatory Consultant 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 to visit clients or conferences if needed and attend 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 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.
  • Design clinical validation approaches — Standalone performance testing, MRMC reader studies, and equivalence analyses.
  • Run client meetings, set agendas, and translate regulatory complexity into clear action items for both technical and executive audiences.
  • Contribute to Innolitics thought leadership — Articles, open tools, and public datasets 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 a beneficial, but not required.

What We Offer 🔗

  • Competitive base salary ($140,000 – $180,000) depending on experience and modifiers such as: FDA experience, post-bachelors education, and number of FDA submissions completed
  • 15–20% 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 🔗

Send your CV, a link to your LinkedIn profile, and a short video (up to 5 minutes) telling us:

  1. Why this article resonates with your work style
  2. Why this role excites you
  3. Describe one FDA submission or regulatory strategy engagement where your AI/ML expertise made a difference
  4. How you stay current with FDA's evolving AI/ML framework and guidance
  5. What AI tools you use and when you would use them

Please email info@innolitics.com with the aforementioned information. Add the name of this job ad in the subject (Senior AI/ML Regulatory Consultant)

We are hiring as soon as we find the right person—so don't hesitate to apply! If selected to move forward, you'll hear from our team within 2–3 business days.