Samd Regulatory Jobs (NOW HIRING)

Location: Remote (U.S. only, excluding Alaska and Hawaii)

Job Type: Full-time

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 .

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.

• 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.

• 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.

• 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