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Regulatory Affairs
Certificate Program

Regulatory Affairs

Guiding the discovery journey

Establish Candidacy View Individual Courses
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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:
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Courses


1. Required Courses: Take seven (7) courses, minimum 14 quarter units.

Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID

05-07-2024 to 06-04-2024
$750.00
REGL.X402.(8)
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Quarter Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID

04-20-2024 to 06-01-2024
$795.00
MEDD.X400.(12)
Want to enroll or get the estimated cost of future sections? Notify Me
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID

04-11-2024 to 06-20-2024
$875.00
REGL.X408.(9)
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Quarter Units: 2.0
Start / End Date
Cost
Instructor
Location
Section ID

07-09-2024 to 08-20-2024
$795.00
REGL.X410.(7)
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Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID

06-01-2024 to 06-15-2024
$750.00
REGL.X401.(11)
Want to enroll or get the estimated cost of future sections? Notify Me
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID

07-06-2024 to 07-27-2024
$875.00
REGL.X400.(12)
Want to enroll or get the estimated cost of future sections? Notify Me
Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID

06-11-2024 to 09-10-2024
$750.00
MEDD.X406.(810)
Want to enroll or get the estimated cost of future sections? Notify Me
Quarter Units: 3.0
Start / End Date
Cost
Instructor
Location
Section ID

04-08-2024 to 05-20-2024
$815.00
MEDD.X407.(14)
Want to enroll or get the estimated cost of future sections? Notify Me
Quarter Units: 2.5
Start / End Date
Cost
Instructor
Location
Section ID
Want to enroll or get the estimated cost of future sections? Notify Me

2. Certificate Review:

Start / End Date
Cost
Instructor
Location
Section ID

3. Related Course(s): These course(s) are not part of the certificate program

Quarter Units: 1.5
Start / End Date
Cost
Instructor
Location
Section ID

04-08-2024 to 05-06-2024
$625.00
CTDM.X407.(10)
Want to enroll or get the estimated cost of future sections? Notify Me

Meet Our Instructors

Bharat (Bill) C Kurani
Associate Vice President/Head of Regulatory Affairs and Quality Assurance
Clarisa A Tate
Director of Regulatory Affairs, USA & Canada, Ypsomed USA
Craig Coombs
President, Coombs Medical Device Consulting
Edward James Rozhon
Program Chair | Retired Sr. Manager, Clinical Operations, Genentech
No image for Farhan Shahab
Senior Director, Quality Assurance and Regulatory Affairs, Intuity Medical
Kiran Gulati
Principal Medical Device Consultant / Exemplar Medical Device Lead Auditor
Narinder Singh
Pharmacy Director, Santa Clara Valley Medical Center
No image for Patrick Lee
Director of Regulatory Affairs, BioCardia, Inc.
Prabhu Raghavan
Consulting VP of Regulatory and Quality for Medical Devices
Thomas  R Pamukcu
CEO, Health Wallet

What students are saying

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

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

northeastern-university-ucsc-extension-regulatory-affairs-transfer-program.png

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 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
  1. Complete a course in your selected program.
  2. Establish candidacy. Click on the Establish Candidacy button on your program page.
  3. Take all required courses for certificate completion.
  4. 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.

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. Personal Financial Planning students have additional grade requirements for individual courses to attain a certificate.

See Grading and Credits Policy for further information.