Regulatory Systems Specialist

Regulatory Systems Specialist

OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries of previous solutions by improving image quality, reducing radiation exposure, improving ease of use, and building solutions to deliver care outside of traditional scenarios. We enable anyone anywhere to access radiologic diagnostics at the point of need, expanding availability and changing how healthcare is delivered.

OXOS is searching for a Regulatory Systems Specialist to join our high-growth company. You will join a dynamic team of passionate people who work daily to change how radiographic diagnostics are delivered. The Regulatory Specialist will execute regulatory processes and manage requirements for innovative radiographic medical devices at OXOS with the aim of changing the way healthcare is delivered. They will ensure compliance with FDA and international regulations while supporting the company's growth objectives through effective regulatory strategy and implementation.

Responsibilities

As the Regulatory Systems Specialist, you will own the end-to-end execution of OXOS submissions and continuously expand the regulatory automation surface. Success in this role means upcoming submissions are generated at the rate of product development, regulatory strategy keeps pace with a rapidly changing landscape, and OXOS develops a durable, compounding advantage in the speed and quality of its regulatory work. Your duties will include, but are not limited to:

• 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. Where possible, run this monitoring through AI agents that surface relevant changes for human review.
• Maintain a current view of predicate devices and the competitive regulatory landscape relevant to upcoming submissions.
• Review and approve marketing materials to ensure compliance with applicable guidances and cleared indications.

• 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.

• 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.
• Maintain a tight feedback loop from real submission work back into the automation system: every miss, edit, or correction becomes an improvement to the prompts, skills, or workflows.
• 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.

Required Skills and 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.

Preferred Qualifications

• Hands-on experience preparing 510(k) submissions for Class II medical devices, particularly radiation-emitting or imaging devices regulated by CDRH.
• Working familiarity with IEC 62304 (medical device software lifecycle) and applicable software-as-a-medical-device guidance.
• Prior experience defining evaluation rubrics, prompt libraries, or structured templates for an AI-augmented workflow.
• Experience with international submissions (EU MDR Technical Files, Health Canada, or similar).

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