FDA Regulatory Specialist – Short Paid Test of AI Tool (Medical Device 510(k) / De Novo
We are developing an AI-powered FDA Regulatory Co-Pilot for medical device classification and regulatory pathway support (510(k), De Novo, etc.).
We are looking for an experienced FDA regulatory specialist to perform a short, structured test of the system and provide brief professional feedback.
Scope of work:
• Spend approximately 1–2 hours testing the tool
• Run 1–2 example device cases through the system
• Review AI outputs (classification, regulatory pathway suggestions)
• Provide a short written report (bullet points are sufficient) covering:
• Accuracy of outputs
• Missing considerations
• Incorrect assumptions (if any)
• Overall professional impression
Important:
This is not a full regulatory project and not a long-term engagement.
This is a short, clearly defined paid test to validate the practical usefulness of the system.
If both sides are satisfied, this may lead to additional testing phases or ongoing collaboration — but this initial task is intentionally limited in scope.
Required experience:
• Practical experience with FDA medical device submissions
• Familiarity with 510(k), De Novo pathways and device classification
• Ability to provide concise, structured professional feedback
We are looking for real-world FDA expertise and practical insight.
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