This course will help students understand the field of Regulatory Affairs (RA) in the context of In Vitro Diagnostics (IVD). The course will examine and develop some key skills that are relevant to the field, and students will understand how RA professionals integrate into their organizations. Students will comprehend the lifecycle of an in vitro diagnostic device, how this differs from pharmaceutics, biologics, non-medical devices and software as medical device, and learn how to address technical challenges as an RA specialist. They will learn how to apply strategic thinking across the product lifecycle. Ultimately, they will understand the expectations of RA professionals at different career stages.