Biomedical Regulatory Affairs

Concentration Focus

The Biomedical Regulatory Affairs Concentration of the Master of Science in Leadership program will empower students with in-depth knowledge, technical and business skills necessary to address FDA-imposed regulation issues throughout the lifecycle of emerging medical products.

Program Content

• Students will understand the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field.
• Students will learn how to locate regulatory information in key national and international sources.
• Students will apply the laws and regulations that govern  the development, testing, and production of medical products, including biotechnology-derived therapeutics and medical devices.
• Students will explore product development, manufacturing, post-marketing requirements, reporting and enforcement.

Who Should Pursue This Concentration?

• Individuals who seek to expand their understanding of regulatory affairs for the drug and medical device industry
• Individuals who want to enter or advance in the biomedical regulatory affairs field, including designers, supervisors, engineers, R&D managers, HR managers.

Career impact of This Concentration

Biomedical Regulatory Affairs builds knowledge and skills necessary to provide leadership and oversight of effective regulatory affairs and compliance. Trine University has recently (June, 2010) become a partner in the OrthoWorx initiative, which is a Warsaw, Indiana based industry, community, and education initiative to support growth and innovation in the region's orthopedics device sector. The "biomedical corridor" with its hub in Warsaw that radiates throughout Northeast Indiana is the largest in the world, hosting 3 of the 5 leading orthopedic device companies. According to the Indiana Health Industry Forum (2008), a total of 84 companies that support biomedical and life sciences exist in this region, all of which must demonstrate internal and external regulatory compliance:

• 9 research and development firms that primarily serve the orthopedic industry,
• 16 manufacturers of orthopedic devices,
• 12 third-tier engineering firms,
• 6 firms that manufacture electromedical apparatuses,
• 15 firms that make surgical and medical equipment,
• 5 manufacturers of surgical appliances,
• 13 firms that make dental equipment, and
• 8 that manufacture hospital equipment and supplies.

According to a Lilly Endowment-funded needs assessment (BioCrossroads, 2009) that established the necessity of OrthoWorx as a coordinating body for education and workforce development, three specific needs were identified that will be met through the delivery of this concentration. First, federal regulatory and compliance scrutiny of the medical device industry has increased tremendously. Second, across the orthopedics device workforce, significant education and training shortfalls have led to a shortage of qualified workers. Third, the industry finds it difficult to attract and retain senior engineering and management talent.

Trine University has proposed, and has been welcomed by the members of OrthoWorx to meet these needs by delivering the Biomedical Regulatory Affairs concentration as both a part of the MSLDR program for individuals charged with leading departments in these companies and a stand-alone certificate program for designers, engineers, and others in the workforce who hold a bachelor's degree and desire only the content-area expertise. These two educational opportunities will equip workers with the capacity to effectively address regulatory issues. Students who complete this concentration area will be equipped to pursue the Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification for U.S. companies (RAC-US) through an examination, which, when passed, will provide a nationally-recognized credential in regulatory affairs (RAPS, 2010).