Regulatory Affairs
Issued by
UCSC Silicon Valley Extension
This individual is able to identify critical roles in the industry, best practices for product documentation and risk management and knows of industry requirements, federal regulations and audits, and global standards. Able to understand and apply good manufacturing practices for drugs, biologics, and medical devices, this professional is equipped to apply risk management principles to products, processes and services within biomedical industries.
- Type Learning
- Level Advanced
- Time Months
- Cost Paid
Skills
Earning Criteria
-
Completed six core courses: Interacting with the FDA; Regulation of Drugs and Biologics; and Regulation of Medical Devices and Diagnostics; at least one each in the Design/Principles track, Submissions track and Quality track; as well as at least two electives. Earned 19 units. Met all requirements for a UCSC Silicon Valley Certificate in Regulatory Affairs.
-
Our Regulatory Affairs program helps prepare professionals with three to five years in the regulatory field for the Regulatory Affairs Certification (RAC) exam. Upon completion, students may transfer credit toward a master's program at Northeastern University.
-
Several UCSC Silicon Valley Extension's Regulatory Affairs certificate courses meet the criteria for pre-approved recertification credit(s) for Regulatory Affairs Certification (RAC). As a Regulatory Affairs Professional Society (RAPS) RAC Recertification Approved Provider, each course is valid for a designated number of PDCs for the RAC recertification requirements.