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Regulatory Affairs Specialists

Also called: Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Specialist (RA Specialist), Regulatory Engineer

What they do:
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.
On the job, you would:
  • 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.

Knowledge

Arts and Humanities
  • English language
Safety and Government
  • law and government
Math and Science
  • biology
Engineering and Technology
  • computers and electronics

Skills

Basic Skills
  • listening to others, not interrupting, and asking good questions
  • talking to others
Problem Solving
  • noticing a problem and figuring out the best way to solve it
People and Technology Systems
  • thinking about the pros and cons of different options and picking the best one
  • figuring out how a system should work and how changes in the future will affect it

Abilities

Verbal
  • read and understand what is written
  • communicate by writing
Ideas and Logic
  • make general rules or come up with answers from lots of detailed information
  • notice when problems happen

Personality

People interested in this work like activities that include data, detail, and regular routines.
They do well at jobs that need:
  • Attention to Detail
  • Integrity
  • Dependability
  • Cooperation
  • Analytical Thinking
  • Persistence

Technology

You might use software like this on the job:

Data base user interface and query software
  • Microsoft Access Hot Technology
  • Structured query language SQL Hot Technology
Medical software
  • Healthcare common procedure coding system HCPCS Hot Technology
  • Medical procedure coding software Hot Technology
Document management software
  • Adobe Systems Adobe Acrobat Hot Technology
  • Atrion Intelligent Authoring

Education

Education: (rated 4 of 5)
bachelor's degree
usually needed

Get started on your career:

Find Certifications Apprenticeship.gov

Job Outlook

Average Outlook
New job opportunities are likely in the future.
Salary
$68,860
$38,320
$109,650
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See more details at O*NET OnLine about regulatory affairs specialists.