Life As a Regulatory Affairs Specialist
Regulatory Affairs Specialist Example 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: What Do They Do?
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
Things a Regulatory Affairs Specialist Should Know How to Do
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.
Other Regulatory Affairs Specialist Job Titles
- Quality Assurance Specialist
- Compliance Analyst
- Clinical Quality Assurance Specialist
- Regulatory Affairs Coordinator
- Regulatory Analyst
Job Outlook 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.
Do Regulatory Affairs Specialists Make A Lot Of Money?
Regulatory Affairs Specialists make between $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|
|District of Columbia||$93,240|
Tools & Technologies Used by Regulatory Affairs Specialists
Although they’re not necessarily needed for all jobs, the following technologies are used by many Regulatory Affairs Specialists:
- Microsoft Excel
- Microsoft Word
- Microsoft Office
- Microsoft PowerPoint
- Microsoft Outlook
- Web browser software
- Microsoft Access
- Microsoft Project
- Adobe Systems Adobe Acrobat
- Microsoft Visio
- Microsoft SharePoint
- Structured query language SQL
- Microsoft Dynamics
- FileMaker Pro
- Microsoft SQL Server
- Medical procedure coding software
- Qlik Tech QlikView
Becoming a Regulatory Affairs Specialist
What education is needed to be a Regulatory Affairs Specialist?
How many years of work experience do I need?
Where Regulatory Affairs Specialists Are Employed
The table below shows the approximate number of Regulatory Affairs Specialists employed by various industries.
More about our data sources and methodologies.