Job Description
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.
Apply Now
Apply Now