Skip to main content

Serving the South Carolina MedTech Industry: New Biomedical Regulatory and Quality Science Certificate Supplies Home-Grown Skilled Workforce

February 9, 2023

As South Carolina’s biomedical industry advances and grows, in-state employers have been struggling to find qualified in-state candidates who can fill regulatory and compliance roles within their company. This in turn forces them to expand their search out of state, which consumes more time and money to find a candidate, if one can even be found.  

Clemson University’s Department of Bioengineering is meeting the need for in-state regulatory and quality medical device and pharmaceutical industry experts head-on by offering a new Biomedical Regulatory and Quality Science Certificate. This certificate is offered in collaboration with Pathway for Patient Health, a global leader spearheading innovative and accessible education in quality science.

Approved by the South Carolina Commission on Higher Education, the graduate certificate spearheaded by Dr. Jeremy Mercuri, John Witherspoon Gilpin, M.D. ’82 Endowed Associate Professor of Bioengineering and Director of the Master of Engineering (M.Eng.) in Biomedical Engineering degree program, is now offered to graduate students and current industry professionals. “This program integrates well with our industry focused M.Eng. curriculum and provides students and their employers with significant value in terms of meeting a growing demand in the medtech industry”, Mercuri said. Subject-matter experts from the medtech industry and Clemson faculty who have substantial experience and expertise in regulatory and quality science deliver the curriculum.  Using real-world case studies, participants not only learn “how” quality and regulation are implemented in industry, but “why” both systems are crucial for the development and manufacturing of pharmaceuticals and medicals devices.

Students pursuing the Biomedical Regulatory and Quality Science certificate learn industry best practices concerning regulatory and quality standards in relation to pre-clinical studies and clinical trials, as well as the design, development, and manufacturing of safe and effective medical devices and pharmaceuticals.

According to Dr. Laura McCallum, Director of the certificate program, this certificate connects students with instructors who have industry experience providing to them the knowledge and skills to manage regulated biomedical products worldwide.  “This program will help produce professionals who will know how to make regulatory decisions to assure competitiveness of their employer”, McCallum said. “Regulation and quality are the bedrock of industry- no matter what role you have in a company. Both are crucial to not only the success of the company, but more importantly, ensuring that your product is safe for a patient and will actually do what it intended to do.”

McCallum, who recently joined the bioengineering faculty from the biopharma manufacturing industry to lead the program, explained that the 14 credit hour certificate courses encompass much more than an overview of regulation and quality as it is now, but also has students understand these standards need to be evaluated and updated constantly.  

Among instructors, Jennifer Mercuri, regulatory science expert and course instructor, has been involved in clinical trials and pre-clinical assessment for medtech devices for numerous years. “What really stood out to me when talking with the industry expert course instructors was their drive to have the students to not only walk away with an understanding of current quality and regulatory standards, but to be able to critically assess those standards to protect patients,” Mercuri said. “As new technology rapidly develops, we need regulation and quality to evolve faster. The only way it will is if we have a specially trained workforce with that ability and mindset.”

Drs. McCallum and Mercuri envision that the Biomedical Regulatory and Quality Science Certificate will streamline the hiring process, by allowing biomedical companies to better identify candidates during interviews that have completed specialized education in regulatory and quality science. This will also provide the opportunity to employers to offer to their current workforce continuing education to meet marketplace demands.

For more information about this certificate, contact BIOE@clemson.edu. Clemson students interested in this certificate can find information here: https://www.clemson.edu/cecas/departments/bioe/academics/certificate.html