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.
List of Regulatory Affairs Specialist Job Duties
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Coordinate recall or market withdrawal activities as necessary.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
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Qualities of a Regulatory Affairs Specialist
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.
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.
Related Job Titles for this Occupation:
- Quality Assurance Specialist
- Regulatory Affairs Associate
- Regulatory Affairs Analyst
- Regulatory Submissions Associate
- Regulatory Affairs Specialist
Job Opportunities for Regulatory Affairs Specialists
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. Due to new job openings and attrition, there will be an average of 25,900 job openings in this field each year.
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.
Average Regulatory Affairs Specialists Salary
The average yearly salary of a Regulatory Affairs Specialist ranges between $38,320 and $109,650.
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?
What kind of Regulatory Affairs Specialist requirements are there?
What work experience do I need to become a Regulatory Affairs Specialist?
Who Employs Regulatory Affairs Specialists?
Below are examples of industries where Regulatory Affairs Specialists work:
References:
More about our data sources and methodologies.
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