Herff's Department of Biomedical Engineering launches program for certificate in regulatory affairs for medical devices
April 29, 2026
Students in the Herff College of Engineering鈥檚 Department of Biomedical Engineering now have more options to expand their careers through Herff鈥檚 Certificate in Regulatory Affairs for Medical Devices.
The Herff College of Engineering launched the program in Spring 2026, providing students with the knowledge and skills necessary to navigate the complex regulatory landscape of the biomedical device industry.
Dr. Gary Bowlin, Chair of Herff鈥檚 Department of Biomedical Engineering, said the college鈥檚 advisory board noticed a growing need in the medical industry, especially at companies like Smith & Nephew, Medtronic and St. Jude Medical, for people who can handle the proper paperwork and regulatory hurdles necessary to market and sell a product with approval from the Food and Drug Administration. Some of those roles include regulatory affairs specialist, quality assurance engineer, clinical research associate, compliance manager and product development consultant.
鈥淚f you look at the local industry, most of the job advertisements for engineers now are regulatory affairs positions, quality control. So, that鈥檚 what drove us, the need for this experience and training for employees in the local industry,鈥� Dr. Bowlin said.
The certificate program comprises four courses and is available to any student, but it primarily targets graduate students and those seeking new pathways in their engineering careers. Students have the opportunity to work with trained faculty and industry professionals to gain the knowledge needed to identify relevant regulatory requirements and documentation for the design, development, testing, manufacture, and marketing of medical devices, ensuring compliance with regulatory agency policies, regulations, and standards.
鈥淥bviously, with medical devices, there鈥檚 a lot of paperwork and regulatory hurdles that need to be overcome before you can start marketing and selling a product. So, this is a way to educate our students who are just potentially entering the workforce because the sector of regulatory affairs is growing with more and more regulations before getting this to market,鈥� Dr. Bowlin said.
The credential builds on degrees in engineering science and technology programs for individuals entering the medical device industry, working in government agencies, or pursuing entrepreneurial opportunities to boost career projects.
鈥淓ach medical device will have its own 'pathway,' which means all the testing and safety data need to be obtained, documented, and submitted for review by the FDA. They鈥檒l send back questions and there will be a lot of back-and-forth hoping to clear the product for clinical use,鈥� Dr. Bowlin said.
Currently, the course is only offered in person at the Herff College of Engineering. Dr. Bowlin acknowledged the challenge this poses for people who want to earn the certificate but are already working full-time jobs. He said he hopes to have the program fully accessible online soon.
If students continue to show interest in the program, Dr. Bowlin said it could eventually be turned into a graduate degree program.
Those interested in earning their certification should contact Dr. Gary Bowlin at glbowlin@memphis.edu.