Definition of Regulatory Affairs Specialists

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.