Study Regulatory Affairs

Navigate the complex world of healthcare regulations and drive innovation with UC Silicon Valley Extension’s Regulatory Affairs and Medical Devices Professional Certificate Programs. Designed for working professionals, aspiring leaders, and those pursuing RAPS certification, our flexible curriculum empowers you to make strategic impact on patient safety and product commercialization.

Program benefits

Industry-centered expertise
Build deep knowledge of regulatory intelligence, FDA negotiation, global regulations, and compliance. Learn best practices directly from industry-wide network instructors.

Certification-ready
Prepare for the Regulatory Affairs Certification (RAC) exam administered by RAPS, gain credits for recertification, and lay foundations for further academic progression.

Flexible, real-world learning
Access online courses tailored for busy professionals and join a network of passionate classmates shaping regulatory strategies for the global marketplace.

What you’ll learn

• Develop global regulatory strategies for medical devices, drugs, and biologics.
• Master regulatory submission writing and risk management across the product lifecycle.
• Apply quality system regulations (GxPS/cGMPS), post-market surveillance, and ethical principles to achieve sustainable compliance.
• Communicate and negotiate with FDA and regulatory agencies to advance organizational goals.
• Demonstrate knowledge across design, development, and compliance—from history files to market corrections.

You will receive

• Mentored instruction
• Industry-aligned curriculum
• Hands-on projects to build your resume
• In-person, remote, flex, weekend, & evening classes
• 9–12 months to complete a certificate
• Approved for workforce funding