Regulatory Expert (SaMD / Digital Therapeutics) to Review FDA Pre-Submission

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We’re looking for a seasoned regulatory consultant with expertise in Software as a Medical Device (SaMD) and digital therapeutics to review our drafted FDA Pre-Submission package. The product is a mobile application for behavioral health. We're looking for a second set of expert eyes to validate our approach and flag any critical gaps or risks ahead of submission. Deliverables: - Review drafts of Pre-Submission document - Provide written or annotated feedback - Potentially: Brief call to discuss project and walk through feedback and recommendations Ideal Experience: - Track record of success in obtaining FDA clearance for software-based medical devices - Hands-on 510(k) and/or De Novo submission experience for Class II SaMD - Familiarity with digital behavioral health tools - Strong grasp of FDA software documentation requirements If there’s a good fit established during this task, we’re also open to ongoing collaboration for the full submission, including documentation support and regulatory guidance through clearance.

Keyword: Project Consultant

Price: $100.0

Regulatory Compliance Healthcare Software