Regulatory Affairs
Guiding the discovery journey
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certificate Description
Regulatory Affairs Certificate Program Updates
Dear Regulatory Affairs Students,
We have recently revised our program to reflect updates in the regulatory affairs industry and consolidate the skills you need in your careers within a single curriculum track. You may refer to our quarterly course catalog for previous requirements. (Oct. 25, 2023)
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.
Program Overview
Estimated Cost: $5,515–$5,765 (You pay only for courses you enroll in.) | International Tuition Cost
Program Requirements: 7 courses. 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.
Special Programs:
Courses
1. Required Courses: Take seven (7) courses, minimum 14 quarter units.
2. Certificate Review:
3. Related Course(s): These course(s) are not part of the certificate program
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.
Also recommended:
Data Privacy and Security for Healthcare and Biosciences, 1.5 units
Professional Development
RAPS credit
Prepare for certification. Earn credit toward recertification
Our courses help prepare professionals with three to five years in the regulatory field for the Regulatory Affairs Certification (RAC) exam, the only post-academic professional credential for regulatory professionals in the healthcare product sector.
Programs related to the scope of regulatory practice as defined by the RAPS competency model and/or the RAC content outlines that meet the RAC recertification requirements are eligible to earn RAC recertification credits. A full-day program may qualify for six credits per day. There is a 12-credit maximum for a multi-day event. For more information on how many points can be earned, see the RAC recertification guide.
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' experience in quality systems and process improvement for the medical device and biotech sectors. She has held positions at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the auditing and quality system training functions and has extensive experience designing and training for companies in domestic and international settings. Since 2001, she has helped medical device startups and established companies achieve successful results during ISO 13485, CE Mark assessments, and FDA audits. Gulati has served as chair of RAPS San Francisco Bay Area chapter and is currently on the RAPS North American Advisory Board. She has been a speaker at conferences sponsored by the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. She has taught for UCSC Extension since 2006 and serves on the advisory boards for the UCSC Extension Medical Devices and Regulatory Affairs certificate programs.
Certificate Program Advisory Committee
MEREDITH BROWN-TUTTLE, BA, RAC, FRAPS
Regulatory Affairs Consultant
Regulatorium
Author, Instructor
KIRAN GULATI, RAB-LA, M.B.A.,
Principal Medical Device Consultant/Exemplar Medical Device Lead Auditor
Kiran Gulati & Associates
Program Chair, Regulatory Affairs, UCSC Silicon Valley Extension
Program Chair, Medical Devices, UCSC Silicon Valley Extension
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
Who should establish candidacy?
- People who are pursuing a certificate (and have enrolled in a course in the program).
- People who want to lock in the current requirements of a certificate or specialization.
4 Simple Steps to a Certificate or Specialization
- Complete a course in your selected program.
- Establish candidacy. Click on the Establish Candidacy button on your program page.
- Take all required courses for certificate completion.
- Once your grades are posted on your final course, enroll in the certificate review fee.
A Benefit of Establishing Candidacy
Program requirements may change. Once you commit to a program by establish your candidacy, you will not have to change your plans to meet new requirements. They are locked in for you. Timeline: 4 years to get it done (or 3 for a specialization) You must complete all the necessary units in a certificate within a four-year window. The clock begins on the first day of your first course in the certificate program. For example, if you started a course on Sept. 5, 2023, you would have to finish by Sept. 4, 2027.
Note: Establishing candidacy does not trigger the beginning of the four-year window. It begins the first day of the first course in your chosen certificate program. The Certificate Completion Review process does not have to occur within the four-year timeframe.
Exceptions to the four-year requirement
- If you Established candidacy prior to Jan. 1, 2024, you will have five years to complete a program.
- Students participating in a special program, such as workforce, international, or our curriculum partner programs, such as the Legal Studies courses (CLS by Barbri) and sales and business courses (Ziplines Education) have shorter completion requirements.
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. Personal Financial Planning students have additional grade requirements for individual courses to attain a certificate.
See Grading and Credits Policy for further information.