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Career Definition of Regulatory Affairs Specialists
Regulatory affairs specialists focus on ensuring organizations are meeting all of the applicable regulations, such as those established by the Food and Drug Administration, for products and services. These specialists do so by completing and filing paperwork with the appropriate local, state, and federal agencies. Regulatory affairs specialists usually work full-time in an office environment. They may work in a variety of industries, including automotive component and tool manufacturing companies.
A primary job responsibility for regulatory affairs specialists is evaluating current and new products for compliance with applicable regulations. Other job duties may include implementing internal organizational audits, handling the notarization of compliance reports, and creating and communicating organizational regulatory work processes. Regulatory affairs specialists will need to stay abreast of new applicable laws and provide organizational management with updates on how the changes will affect the business.
These specialists can create and maintain an electronic or hard copy filing system for organizational records. Regulatory affairs specialists can also create and implement compliance strategies for newly developed products. They could oversee the process of replying to requests from customers or vendors. Regulatory affairs specialists could also work with departments like engineering or product management to ensure the creation and delivery of compliance-oriented customer services. These specialists may evaluate marketing or promotional materials to guarantee all information meets compliance standards.
|Educational Requirements||Bachelor's degree|
|Job Skills||Excellent analytical abilities, strong communication skills, and effective attention to detail|
|Median Salary (2017)*||$57,323 (Regulatory Affairs Specialist I)|
|Job Outlook (2016-2026)**||8% (Compliance Officers)|
Sources: *Salary.com, **U.S. Bureau of Labor Statistics
Individuals will need a bachelor's degree in product safety, chemistry, or a related field to work as a regulatory affairs specialist. A strong knowledge of domestic and international regulations will be beneficial. Interested individuals can seek membership in industry organizations like the Regulatory Affairs Professionals Society. The organization offers members certification, training, and networking opportunities.
Excellent analytical abilities are one of the most important skills for regulatory affairs specialists, as they must utilize their regulatory knowledge to ensure organizations are in compliance. Regulatory affairs specialists should have strong communication skills in order to collaborate with colleagues and interface with vendors, customers, or sales representatives as needed. They should also have effective attention to detail in order to successfully oversee regulatory initiatives.
Career Outlook and Salary
The U.S. Bureau of Labor Statistics (BLS) does not collect statistics on regulatory affairs specialists; however, they reported an 8% growth for compliance officers during 2016-2026. This growth is as fast as the average for all occupations. In November 2017, Salary.com reported a median annual salary of $57,323 for regulatory affairs specialists.
Individuals considering a career as a regulatory affairs specialist might also be interested in one of the related careers profiled below. They offer candidates the opportunity to utilize their skills in other compliance-related positions.