Regulatory Affairs Specialist, Software as a Medical Device
Gets the software through the FDA. Without this role the product is a demo, not a product.
Quick facts
- Which side
- Vendor
- Remote?
- Often remote or hybrid. The work is documents, submissions and meetings, and plenty of these teams are distributed.
- How people get in
- Regulatory affairs from traditional medical devices, or a science background plus a certificate. The software specialization is recent enough that most people in it moved sideways from hardware devices.
- Pressure from AI
- Low. The FDA reviews submissions written by people, and the volume of AI submissions has been climbing for years.
What the Job Actually Is
Every product in this site's cleared directory got there because somebody did this job.
The work is deciding which device type the product should be filed under, assembling the evidence the FDA will want, writing the submission, and answering the questions that come back. Choosing the device type is the part that matters most and gets the least attention, because it sets the ceiling on what the product is allowed to claim forever after.
It is also the role that has to tell the founders that the marketing site cannot say what they want it to say.
What You Need to Be Good At
- Knowing the device types and what each one permits
- Building a predicate argument that survives review
- Writing for a regulator rather than for a customer
- Change control planning, which is how a model gets updated after clearance without starting over
Pay
No range is published here. The official United States wage source is the Bureau of Labor Statistics wage survey, which this site cannot query, and every other figure floating around for these roles is scraped or self-reported on a tiny sample. A made-up number would be worse than none.
This is a description of a kind of work, not a job posting, and no openings are listed. Descriptions are editorial and reflect how these teams are commonly staffed rather than any single employer's definition.