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Study Regulatory Affairs with Silicon Valley Experts

We'll help you build a career at the intersection of innovation, ethics, and global compliance

   

Are you ready to make a meaningful impact in healthcare, medical devices, and life sciences? The Regulatory Affairs Certificate Program at UCSC Silicon Valley Extension provides the skills, credentials, and real-world experience you need to succeed in the fast-growing field of regulatory affairs and compliance.

Whether you're entering the industry or expanding your expertise, our fully online program is designed for working professionals and those preparing for the Regulatory Affairs Certification (RAC) exam.

• Mentored instruction
• Industry-aligned curriculum
• Hands-on projects to build your resume
• In-person, remote, flex, weekend, & evening classes
• Practical skills you can bring to work
• 9–12 months to complete a certificate
 

🎯 What you’ll learn

Our curriculum blends regulatory science, global compliance, and product lifecycle strategy, giving you the confidence to:

  • Develop global regulatory strategies for medical devices, biologics, and pharmaceuticals
  • Navigate FDA interactions and prepare professional regulatory submissions
  • Apply risk management throughout the product lifecycle
  • Understand and implement Good Manufacturing Practices (GxPs/cGMPs)
  • Stay current on ISO 13485 and FDA Quality System Regulations
  • Conduct post-market surveillance, including recalls and corrections
  • Communicate regulatory strategies to executives and negotiate with global agencies
  • Prepare for the RAC exam and maintain RAC certification through approved coursework
 

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