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Regulatory Affairs Specialists

Job Zone 4 - Considerable preparation needed

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Pay & job outlook

Median pay: $80,730/yr (U.S. national, May 2025)

$48,220$133,720

Typical range nationwide (10th–90th percentile). This is a population snapshot, not a personal prediction - actual pay varies by location, employer, and experience.

Job outlook: +3% projected growth, 20242034 — about as fast as average.

About 33,300 openings per year, on average, over the decade.

Typical entry-level education: Bachelor's degree.

Source: U.S. Bureau of Labor Statistics, OEWS and Employment Projections.

Top skills
WritingActive ListeningSpeakingCritical ThinkingJudgment and Decision MakingReading ComprehensionComplex Problem SolvingSystems AnalysisSocial PerceptivenessTime Management
Top knowledge areas
English LanguageLaw and GovernmentBiologyComputers and ElectronicsAdministration and ManagementAdministrativeChemistryMedicine and Dentistry
Core tasks

Coordinate efforts associated with the preparation of regulatory documents or submissions.

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

Prepare or maintain technical files as necessary to obtain and sustain product approval.

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

Coordinate recall or market withdrawal activities as necessary.

Frequently asked questions

What's the median pay for Regulatory Affairs Specialists?

The median pay for Regulatory Affairs Specialists is $80,730 per year, per the U.S. Bureau of Labor Statistics.

What's the job outlook for Regulatory Affairs Specialists?

Employment for Regulatory Affairs Specialists is projected to change +3% from 2024 to 2034 - about as fast as average.

What education is typically required for Regulatory Affairs Specialists?

Typical entry-level education: Bachelor's degree.

How many job openings are there each year for Regulatory Affairs Specialists?

About 33,300 openings per year, on average, over the decade.