Regulatory Systems Specialist

Responsibilities

• Drive Regulatory Strategy
• Develop and maintain comprehensive regulatory strategies for OXOS products in the U.S. and select international markets.
• Evaluate country-specific regulations, industry guidance, and testing requirements that impact product clearance and market access.
• Monitor and analyze regulatory changes in standards and FDA guidance, and assess their impact on OXOS products.
• Review and approve marketing materials to ensure compliance with applicable guidances and cleared indications.
• Own Regulatory Submissions
• Prepare and submit 510(k)s, Q-submissions, and Technical Files for the U.S. and select international markets, owning timelines and content quality end-to-end.
• Monitor and report on submission status; manage FDA correspondence and responses to Additional Information requests.
• Collaborate with strategy, project management, engineering, quality, and clinical teams to ensure submission inputs are timely, accurate, and traceable.
• Maintain efficient systems for regulatory records management.
• Establish and maintain effective, cordial, and professional relationships with regulators at the state and federal levels.
• Co-Build Regulatory Automation Systems
• Partner with the AI team to identify the highest-leverage manual regulatory processes for automation, prioritizing those tied to upcoming submissions and active strategy work.
• Co-author agent prompts, skills, and structured templates that encode OXOS regulatory know-how (predicate research, section drafting, traceability matrices, change-impact analysis, response drafting, and more).
• Define and run evaluations that determine whether AI-generated regulatory artifacts are submission-grade — including rubrics, gold-standard examples, and defect taxonomies.
• Operate agentic AI tools (e.g., Claude Code) as a daily-driver power user, directing them to draft, review, and refactor regulatory content under regulatory supervision.

Requirements

• Bachelor’s Degree or higher in Biomedical Engineering, Life Sciences, Regulatory Affairs or related field.
• Regulatory expertise.
• Deep working knowledge of 510(k), QMS (ISO 13485), IEC 60601, ISO 14971, and FDA Q-Sub processes, with the ability to recognize regulatory risk and identify bright lines on sight.
• Submission experience. Demonstrated involvement in 510(k), De Novo, or PMA submissions for medical devices, including direct interaction with FDA review teams.
• AI tool fluency. Power-user comfort with agentic AI tools (e.g., Claude Code, Cursor) to direct multi-step regulatory tasks, review generated artifacts and code, and iterate quickly without needing to write code from scratch.
• Systems thinking. Ability to see recurring manual work as a system to improve, decomposing regulatory workflows into discrete, automatable steps with clear inputs, outputs, and quality bars.
• Evaluation and judgment. Ability to assess when an AI-generated regulatory artifact meets the bar for submission, including designing evaluation criteria, building gold-standard examples, and treating defects as system-level signals.
• Attention to detail. Pedantic accuracy across lengthy, technical submission documents to avoid non-compliance, audit deficiencies, and errors inherited by downstream automation.
• Communication. Clear, precise written and verbal communication across regulators, engineering, clinical, quality, and AI teams, with the ability to adjust style without losing precision.
• Organization. Maintains regulatory materials as a single, authoritative source of truth in both human- and machine-readable form to support reliable automated workflows.
• Problem-solving. Solves regulatory problems creatively to unblock engineering rather than impede it.
• Teamwork. Collaborates deeply across all teams, with especially close partnership with the AI team to co-build regulatory automation.

Qualifications

• Bachelor’s Degree or higher in Biomedical Engineering, Life Sciences, Regulatory Affairs or related field.
• Regulatory expertise.
• Deep working knowledge of 510(k), QMS (ISO 13485), IEC 60601, ISO 14971, and FDA Q-Sub processes, with the ability to recognize regulatory risk and identify bright lines on sight.
• Submission experience. Demonstrated involvement in 510(k), De Novo, or PMA submissions for medical devices, including direct interaction with FDA review teams.
• AI tool fluency. Power-user comfort with agentic AI tools (e.g., Claude Code, Cursor) to direct multi-step regulatory tasks, review generated artifacts and code, and iterate quickly without needing to write code from scratch.
• Systems thinking. Ability to see recurring manual work as a system to improve, decomposing regulatory workflows into discrete, automatable steps with clear inputs, outputs, and quality bars.
• Evaluation and judgment. Ability to assess when an AI-generated regulatory artifact meets the bar for submission, including designing evaluation criteria, building gold-standard examples, and treating defects as system-level signals.
• Attention to detail. Pedantic accuracy across lengthy, technical submission documents to avoid non-compliance, audit deficiencies, and errors inherited by downstream automation.
• Communication. Clear, precise written and verbal communication across regulators, engineering, clinical, quality, and AI teams, with the ability to adjust style without losing precision.
• Organization. Maintains regulatory materials as a single, authoritative source of truth in both human- and machine-readable form to support reliable automated workflows.
• Problem-solving. Solves regulatory problems creatively to unblock engineering rather than impede it.
• Teamwork. Collaborates deeply across all teams, with especially close partnership with the AI team to co-build regulatory automation.

Benefits and Perks

• Health, Dental, and Vision Insurance
• Competitive pay and equity in the company
• 401(k)
• The opportunity to work with an innovative, early-stage company that is changing medical imaging as we know it
• Endless opportunities for growth and development in a rapidly growing medical company
• Salary Range: $100k to $120k