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The Concentration

The Biomedical Regulatory Affairs Concentration 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.

Students will:

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

available to adult students

available to online students

The Experience

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

The Results

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.