Regulatory Affairs Manager (Medical Devices)

Also called: Regulatory Manager

Guides new medical devices through FDA approval and keeps them compliant.

A day in the life

Assembles thousands of pages of test data into an FDA submission, meets with engineers about what evidence the agency will want, and decides whether a design change needs re-approval.

Pay over a career

Starting
$100k
Typical
$140k
High
$190k

Estimate.

Approximate: anchored on Bureau of Labor Statistics data for a broader job group.

Training

Bachelor's degree (4-year), about 8 years after high school. Bachelor's in science or engineering plus years of regulatory experience; RAC certification helps.

Ways in: 4-year college, Graduate school, Certification. Training cost: $15k – $60k.

Majors to look at: Biomedical Engineering, Biology, Regulatory Science.

Outlook

Growing faster than average. Steady with strong industry demand.

Will it last? Our AI estimate

Medium risk for 10 years. AI drafts and cross-checks FDA submissions; strategy calls and negotiating with regulators stay human, with leaner teams.

Start now, in high school

Classes: Biology, English composition, Chemistry.

Official data: O*NET occupation 11-9199.

More Medical Devices & Biomedical Engineering careers

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.