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Regulatory Affairs Specialist

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What Do Regulatory Affairs Specialist Do?

Occupation Description 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.

Regulatory Affairs Specialist Responsibilities

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

What Every Regulatory Affairs Specialist Should Know

These are the skills Regulatory Affairs Specialists say are the most useful in their careers:

Active Listening: Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Writing: Communicating effectively in writing as appropriate for the needs of the audience.

Speaking: Talking to others to convey information effectively.

Reading Comprehension: Understanding written sentences and paragraphs in work related documents.

Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Types of Regulatory Affairs Specialist Jobs

  • Clinical Quality Assurance Associate
  • Compliance Analyst
  • Product Safety Specialist
  • Compliance Consultant
  • Regulatory Submissions Associate

What Kind of Regulatory Affairs Specialist Job Opportunities Are There?

In 2016, there was an estimated number of 288,300 jobs in the United States for Regulatory Affairs Specialist. New jobs are being produced at a rate of 8.2% which is above the national average. The Bureau of Labor Statistics predicts 23,700 new jobs for Regulatory Affairs Specialist by 2026. There will be an estimated 25,900 positions for Regulatory Affairs Specialist per year.

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The states with the most job growth for Regulatory Affairs Specialist are Utah, Nevada, and Washington. Watch out if you plan on working in Alaska, Maine, or Maryland. These states have the worst job growth for this type of profession.

How Much Does a Regulatory Affairs Specialist Make?

The average yearly salary of a Regulatory Affairs Specialist ranges between $38,320 and $109,650.

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Regulatory Affairs Specialists who work in District of Columbia, Alaska, or California, make the highest salaries.

How much do Regulatory Affairs Specialists make in each U.S. state?

State Annual Mean Salary
Alabama $67,700
Alaska $80,840
Arizona $64,340
Arkansas $56,820
California $82,380
Colorado $73,710
Connecticut $84,590
Delaware $77,670
District of Columbia $93,240
Florida $63,890
Georgia $63,030
Hawaii $69,980
Idaho $59,420
Illinois $74,180
Indiana $61,970
Iowa $63,340
Kansas $60,030
Kentucky $58,260
Louisiana $61,230
Maine $66,230
Maryland $77,250
Massachusetts $83,100
Michigan $71,470
Minnesota $76,190
Mississippi $54,700
Missouri $62,180
Montana $62,620
Nebraska $68,610
Nevada $67,540
New Hampshire $70,670
New Jersey $83,210
New Mexico $68,290
New York $76,370
North Carolina $67,100
North Dakota $70,970
Ohio $67,140
Oklahoma $59,340
Oregon $71,860
Pennsylvania $71,090
Rhode Island $76,440
South Carolina $61,390
South Dakota $57,930
Tennessee $61,780
Texas $74,690
Utah $59,470
Vermont $69,520
Virginia $75,900
Washington $84,340
West Virginia $60,740
Wisconsin $62,700
Wyoming $67,370

What Tools do Regulatory Affairs Specialists Use?

Below is a list of the types of tools and technologies that Regulatory Affairs Specialists may use on a daily basis:

  • Microsoft Excel
  • Microsoft Word
  • Microsoft Office
  • Microsoft PowerPoint
  • Microsoft Outlook
  • Web browser software
  • Microsoft Access
  • SAP
  • Microsoft Project
  • Adobe Systems Adobe Acrobat
  • Microsoft Visio
  • Microsoft SharePoint
  • Structured query language SQL
  • Microsoft Dynamics
  • FileMaker Pro
  • Microsoft SQL Server
  • LexisNexis
  • Medical procedure coding software
  • MicroStrategy
  • Qlik Tech QlikView

How do I Become a Regulatory Affairs Specialist?

Learn what Regulatory Affairs Specialist education requirements there are.

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How many years of work experience do I need?

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Where do Regulatory Affairs Specialists Work?

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Below are examples of industries where Regulatory Affairs Specialists work:

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References:

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