Regulatory Affairs
Certificate Program

Regulatory Affairs

Guiding the discovery journey

Enroll in Certificate View Individual Courses

Certificate Description


Medical discovery and commercialization

Students learn the journey of safe and ethical medical device and drug development. You will identify the critical roles in the industry, best practices for product documentation and risk management. Learn industry requirements, federal regulations and audits and global standards. Network with people in the industry.

Regulatory Affairs certificate program objectives

  • Provide regulatory submissions of drugs and biologics
  • Differentiate the roles and responsibilities between quality assurance (QA) and quality control (QC)
  • Understand and apply GXPS (Good Manufacturing Practices (GMPS)/Quality System Regulation) for drugs/biologics/medical devices.
  • Apply risk management principles to products, processes and services within biomedical industries
  • Set up and implement medical device verification and validation programs

Required Credits: Total Required: 8–10 courses (19 units). Take 6 core courses (3 designated, plus one each from three categories) (13.5–15.5 units) and 2–4 elective credit courses (5 units). End with certificate of completion review.
Duration: A full-time student can complete the certificate in 9–12 months.

Courses

Course Units Fall Winter Spring Summer
1. Required Courses
Interacting with the FDA 1.5
Regulation of Drugs and Biologics 3.0
Regulation of Medical Devices and Diagnostics 3.0 Winter TBD
2. Required Track (A); Choose 1 of the 2 courses
Design Control for Medical Devices 2.0
Principles of Drug Discovery and Development 4.0
3. Required Track (B); Choose 1 of the 2 courses
Regulatory Submissions: Devices and Diagnostics 2.5
Regulatory Submissions: Drugs and Biologics 2.0
4. Required Track (C); Choose 1 of the 2 courses
Good Manufacturing Practices 3.0
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 2.5
5. Elective Courses (choose 2-4 courses to bring total program units to 19)
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0 Winter TBD
Global Medical Device Submissions and Strategy 1.5
Good Clinical Practices 3.0
Post-Market Regulatory Obligations for Medical Devices 1.5
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Regulation of in vitro Diagnostics in Europe and the US 2.5
Risk Management for Regulated Industries 3.0
Validating Software for Medical Devices and Emerging Technologies 2.0
Value-Added Quality Audits 1.5
6. Additional Courses of Interest
Clinical Trials Essentials: An Intensive One-Week Course 3.5
Data Privacy and Security for Healthcare and Biosciences 1.5
7: Fee for Certificate Review
Regulatory Affairs Certificate Completion Fee None

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

Professional Development

Regulatory Affairs certification

Helps 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.

Transfer your Regulatory Affairs certificate units to a master's program

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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

Kiran Gulati, Chair

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-TUTTLEBA, 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 MAHARAJHMS, BS
Director, R&D
Carl Zeiss Meditec, Inc.

JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.

Declaring Candidacy

You can enroll in a certificate program any time during your studies.

Once you create your student account, you can enroll in a certificate program. Although you can enroll in a program at any time, the benefit of enrolling early is that it locks in your certificate requirements. This means that even if program requirements change, the requirements to complete your certificate will remain the same for you.

  • You must enroll in the certificate program before enrolling in the Certificate Completion Review.

You have a total of five years to complete all necessary courses in a certificate program.

All the necessary units in a certificate must be completed within a five-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, 2017, you would have to complete all of the required units in this certificate by Sept. 4, 2022.

  • Enrolling in a certificate program does not trigger the beginning of the five-year window. It begins the first day of the first course that applies to a certificate program.
  • The Certificate Completion Review process does not have to occur within the five-year timeframe.

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.

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