Also called: Regulatory Affairs Director, RA Manager
Leads the process of getting new medical devices approved by the FDA and other countries.
You plan the testing a new heart valve needs before the FDA will approve it, review a 2,000-page submission, and join a call with FDA reviewers who have questions about the clinical data.
Approximate: anchored on Bureau of Labor Statistics data for a broader job group.
Master's degree, about 6 years after high school. Bachelor's in engineering or science plus years of experience; RAC certification; master's common.
Ways in: 4-year college, Graduate school, Certification. Training cost: $60k – $150k.
Majors to look at: Biomedical Engineering, Bioengineering, Regulatory Science.
Growing faster than average. Strong demand in medtech.
Medium risk for 10 years. AI drafts submissions and tracks global rule changes, shrinking teams; strategy, FDA negotiations and accountability stay human.
Classes: AP Biology, English composition, Government or civics, Chemistry.
Official data: O*NET occupation 11-9041.
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