Life As a Regulatory Affairs Specialist
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.
Life As a Regulatory Affairs Specialist
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Develop or conduct employee regulatory training.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Analyze product complaints and make recommendations regarding their reportability.
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Regulatory Affairs Specialist Needed Skills
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.
Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Related Job Titles
- Regulatory Analyst
- Clinical Quality Assurance Associate
- Regulatory Compliance Specialist
- Regulatory Associate
- Compliance Consultant
Is There Going to be Demand for Regulatory Affairs Specialists?
There were about 288,300 jobs for Regulatory Affairs Specialist in 2016 (in the United States). 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. The BLS estimates 25,900 yearly job openings in this field.
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.
Regulatory Affairs Specialist Salary
The salary for Regulatory Affairs Specialists ranges between about $38,320 and $109,650 a year.
Regulatory Affairs Specialists who work in District of Columbia, Alaska, or California, make the highest salaries.
Below is a list of the median annual salaries for Regulatory Affairs Specialists in different U.S. states.
| 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 & Technology 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 SharePoint
- Microsoft Visio
- Structured query language SQL
- Microsoft Dynamics
- FileMaker Pro
- Microsoft SQL Server
- LexisNexis
- Medical procedure coding software
- Human resource management software HRMS
- MicroStrategy
How to Become a Regulatory Affairs Specialist
What education is needed to be a Regulatory Affairs Specialist?
What work experience do I need to become a Regulatory Affairs Specialist?
Where Regulatory Affairs Specialists Are Employed
The table below shows some of the most common industries where those employed in this career field work.
References:
More about our data sources and methodologies.
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