Regulatory Affairs

Medical discovery and commercialization

Students in the Regulatory Affairs certificate program learn to navigate the intricate regulatory landscape of medical devices. They embark on a journey of discovery that emphasizes patient safety, ethics, and compliance, gaining a thorough understanding of regulatory intelligence, federal regulations, and global regulatory requirements. Students learn:

• Best practices for interacting and negotiating with the FDA.
• Regulatory submission writing.
• Risk management strategies in the product lifecycle.
• A foundation for the Regulatory Affairs Certification (RAC) exam (administered by the Regulatory Affairs Professionals Society).

Join our industry-wide network of instructors and classmates who share your passion for developing regulatory strategies for the global marketplace.

Skills for a career in regulatory affairs

• Develop a global regulatory strategy for medical devices, drugs, and biologics.
• Identify how regulatory affairs and quality compliance professionals contribute to an organization’s bottom line by keeping up with global regulatory requirements.
• Understand and apply good manufacturing practices (GxPS/cGMPS) and quality system regulation for drugs, biologics, and medical devices to help an organization achieve sustainable compliance.
• Apply risk management principles when conducting post-market surveillance activities such as recalls and market corrections.
• Communicate in writing and verbally with corporate executives.
• Negotiate with regulatory agencies such as the FDA.
• Demonstrate knowledge of the design and development life cycle approach for drugs and biologics medical devices and have knowledge on how to compile a design history.