Regulatory Affairs
Guiding the discovery journey
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certificate Description
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.
Regulatory Affairs certificate program learning objectives
- 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.
Prepare for RAPS certification. Earn credit toward recertification.
A RAC Recertification Approved Provider
UCSC Silicon Valley Professional Education is a Regulatory Affairs Professional Society (RAPS) RAC Recertification Approved Provider. See the Professional Development section below for courses that meet RAC recertification requirements to maintain the credential.
Program Overview
Estimated Cost: $5,515–$6,000 + est. course materials: $750 (You pay only for courses you enroll in.) | International Tuition Cost
Program Requirements: 7 courses (14 quarter units). End with certificate of completion review.
Minimum Hours of Instruction: Minimum 140 hours of instruction.
Estimated Duration: A full-time student can complete the certificate in 9–12 months.
Modality: This is a fully online program with live-online & self-paced course formats.
Special Programs: This program is not approved for workforce or international students.
Courses
1. Required Courses: Take seven (7) courses, minimum 14 quarter units.
2. Certificate Review:
Meet Our Instructors
What students are saying
"That next person you say hello to at the class in Extension may give you a lead to your next job. People in my classes all worked at some of the biggest companies in the area, from Gilead to Genentech."
— Fred Bauzon
Field Application Scientist and Molecular Biologist
Certificate Inquiry Form
Recommended Course Sequence
Begin with Quality Systems for Medical Devices FDA QSR and ISO 13485 (formerly Medical Device Quality Systems) or Foundations of Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment, followed by Global Medical Device Submissions and Strategy.
After that, courses may be taken in any order provided the prerequisites are met.
Substitutions
To receive your certificate
Complete the course sequence before requesting your Regulatory Affairs Certificate Completion Review.
Professional Development
Earn RAPS credit toward your credential
Prepare for certification. Earn credit toward recertification.
UCSC Silicon Valley Professional Education is a Regulatory Affairs Professional Society (RAPS) RAC Recertification Approved Provider. The five courses below meet RAC recertification requirements to maintain the credential.
- Design Control for Medical Devices
Approved for 15 RAC recertification credits - Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements
Approved for 15 RAC recertification credits - Communicating and Negotiating with the FDA
Approved for 14 RAC recertification credits - Global Medical Device Submissions and Strategy
Approved for 14 RAC recertification credits - Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment
Approved for 15 RAC recertification credits
Visit the RAC website for more information.
Visit the RAC website for more information.
Transfer your Regulatory Affairs certificate units to a master's program
Completion of the UCSC Silicon Valley Extension Regulatory Affairs certificate program counts toward a maximum of 12 graduate credits to the Northeastern University College of Professional Studies Master's Degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices program. The Northeastern program is 100 percent online, requires 45 semester hours, and includes concentrations in seven high-demand fields.
Licensure and certification
Courses in the Regulatory Affairs program help prepare professionals (with three to five years in the regulatory field) for the Regulatory Affairs Certification (RAC) exam. It is an optional exam for the industry.
Please see our Licensure and Certification Policy to learn more.
Requisite Knowledge
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education. Students with a basic understanding of the life sciences and strong written and oral communication skills will gain the most from this program.
Advisory Board
Certificate Program Chair
KIRAN GULATI, RAB-LA, M.B.A., is a management consultant with more than 25 years of experience in quality systems and process improvement for the medical device and biotech sectors.
Learn more.
Certificate Program Advisory Committee
MEREDITH BROWN-TUTTLE, BA, RAC, FRAPS
Regulatory Affairs Consultant
Regulatorium
Author, Instructor
NANCY E. ISAAC, JD, MPH
Regulatory Counsel and VP Quality
Moximed, Inc.
NIRANJAN MAHARAJH, MS, BS
Director of Engineering
Johnson & Johnson MedTech
Instructor, Medical Devices, UCSC Silicon Valley Extension
JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.
Establish Candidacy
Grade Requirements
Please note that only letter grades of C or higher may be applied to a certificate, and in some programs, students may have more stringent requirements. Students in most employer- and government-sponsored payment programs, such as workforce development, as well as international students on F-1 visas, need to maintain a B average to meet their requirements.
See Grading and Credits Policy for further information.