Do you want to apply for this freelance job vacancy?
Yes No

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

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

What is your current level of experience in freelance work?

Select your experience level None Beginner Intermediate Advanced

 

Next

How many hours per week do you plan to work?

Select your weekly working hours Up to 10h 10h to 20h 20h to 40h Full-time

 

Next

Which language do you speak fluently?

Select your fluent language Portuguese English Spanish French Other

 

Next

What are you looking for?

Select your goal Supplement income Change career Work 100% remotely Professional growth

 

Next

Perfect! Questions answered.

View opportunities now

Registration

Full Name

Email Address

Password

Confirm Password

Register and access opportunities