Also called: RA Specialist, Medical Device Regulatory Engineer
Prepares the paperwork and evidence that prove a medical device is safe enough for the FDA to approve.
You gather test reports for a new blood-pressure cuff, check every claim on its label, and assemble the FDA 510(k) submission. When regulators ask questions, you track down answers from the engineers.
Approximate: anchored on Bureau of Labor Statistics data for a broader job group.
Bachelor's degree (4-year), about 4 years after high school. Bachelor's in engineering or life sciences; RAC certification helps.
Ways in: 4-year college, Certification. Training cost: $15k – $60k.
Majors to look at: Biomedical Engineering, Bioengineering, Biology.
Growing faster than average.
Medium risk in 5 years, high in 10. AI drafts submissions, checks documents and tracks rules, so fewer specialists are needed; judgment on evidence and FDA talks stay human.
Classes: English composition, Biology, Chemistry, Government or civics.
Official data: O*NET occupation 13-1041.
Career Universe is an early version. Pay, training and AI-risk figures are estimates to start your own research, not verified facts. The research was written with AI research assistants, checked by validation scripts and spot-checked by hand. Check anything important with schools, employers and official sources. How the numbers work.