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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

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.

RAPS Recertification Approved Provider | Regulator Affairs Certification (RAC)

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

Syllabus Library Detail View
Course Quarter Units Fall Winter Spring Summer
1. Required Courses: Take seven (7) courses, minimum 14 quarter units.
Communicating and Negotiating with the FDA 1.5
Design Control for Medical Devices 2.0
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment 2.0
Global Medical Device Submissions and Strategy 1.5
Good Manufacturing Practices 3.0
Post-Market Regulatory Obligations for Medical Devices 1.5
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 3.0 +
Regulatory Submissions: Devices and Diagnostics 2.5
2. Certificate Review:
Regulatory Affairs Certificate Completion Fee None

Meet Our Instructors

Bharat (Bill) C Kurani

Bharat (Bill) C Kurani

Associate Vice President/Head of Regulatory Affairs and Quality Assurance
Clarisa A Tate

Clarisa A Tate

Director of Regulatory Affairs, USA & Canada, Ypsomed USA
Craig Coombs

Craig Coombs

President, Coombs Medical Device Consulting
Edward James Rozhon

Edward James Rozhon

Program Chair | Retired Sr. Manager, Clinical Operations, Genentech
Farhan Shahab

Farhan Shahab

Vice President, Quality and Regulatory, Welldoc
Jay Vaishnav

Jay Vaishnav

Jay Vaishnav, Industry Regulatory Affairs Professional
Katherine Stephenson

Katherine Stephenson

Founder | Principal, Dyad Engineering | Grant Reviewer
Kiran Gulati

Kiran Gulati

Principal Medical Device Consultant / Program Chair
Michelle A Carpenter

Michelle A Carpenter

Executive Vice President, Regulatory Affairs at Star Therapeutics
Narinder Singh

Narinder Singh

Pharmacy Director, Santa Clara Valley Medical Center
No image for Patrick Lee

Patrick Lee

Director of Regulatory Affairs, BioCardia, Inc.
Prabhu Raghavan

Prabhu Raghavan

Consulting VP of Regulatory and Quality for Medical Devices
Thomas R Pamukcu

Thomas R Pamukcu

CEO, Health Wallet

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

Fred Bauzon
Program: Regulatory Affairs

Certificate Inquiry Form

Contact Us

Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

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.

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

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 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

Steps for Establishing Candidacy

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.