What Does it Take to Be a Regulatory Affairs Specialist?

Position 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.

Daily Life Of a Regulatory Affairs Specialist

• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• 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.
• Develop or track quality metrics.
• Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

Things a Regulatory Affairs Specialist Should Know How to Do

Regulatory Affairs Specialists state the following job skills are important in their day-to-day work.

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.

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

Types of Regulatory Affairs Specialists

• Regulatory Associate
• Clinical Quality Assurance Specialist
• Regulatory Affairs Consultant (RA Consultant)
• Compliance Associate
• Quality Assurance Specialist

What Kind of Regulatory Affairs Specialist Job Opportunities Are There?

In the United States, there were 288,300 jobs for Compliance Officers in 2016.

New jobs are being produced at a rate of 8.2% which is lower than average. The Bureau of Labor Statistics predicts 23,700 new jobs for Regulatory Affairs Specialists by 2026. The BLS estimates 25,900 yearly job openings in this field per year.

The states with the most job growth for Compliance Officers are Texas, California, and New York.

Watch out if you plan on working in Alaska, Wyoming, or Maine. These states have the worst job growth for this type of profession.

What is the Average Salary of a Regulatory Affairs Specialist

The salary for Compliance Officers ranges between about $38,320 and $109,650 a year. The median salary is $68,860.

Below is a list of the median annual salaries for jobs of this type in different U.S. states.

Annual Mean Salary by State

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

What Tools & Technology do Regulatory Affairs Specialists Use?

Although they’re not necessarily needed for all jobs, the following technologies are used by many Regulatory Affairs Specialists:

• Microsoft SharePoint
• Healthcare common procedure coding system HCPCS
• Fund accounting software
• Microsoft Outlook
• Microsoft PowerPoint
• Structured query language SQL
• Microsoft Excel
• MicroStrategy
• Medical procedure coding software
• Relational database management software

Who Employs Regulatory Affairs Specialists?

References

Bureau of Labor Statistics

College Factual

O*NET Online

Image Credit: Via Wikimedia Commons