Program
Requirements
Complete admission and program requirements are found in the University Catalog.
Courses
The graduate certificate in Regulatory Affairs offers you foundational courses in regulatory affairs for medical devices. Whether you are a professional working with or in a medical device company or a regulatory professional seeking to refresh your skills or gain additional regulatory credentials, you will benefit from this basic education in medical device-related regulatory requirements. The certificate is also an efficient transition option for students seeking the master’s degree in Regulatory Affairs and Services.
The program is 16 credits comprised of six professional core credits and 10 credits of restricted electives. Students can start any semester.
Designed for working professionals, the program can be completed in 12-15 months by completing five courses. The program uses curriculum from the Regulatory Affairs and Services, Medical Technical Quality and Applied Clinical Research programs.
Courses are offered on Saturday mornings and weeknights at the Twin Cities Graduate Center in Maple Grove and is open to students nationally via a synchronous Adobe Connect Internet connection.
Designed by respected industry professionals, the program is taught by industry experts with 10-20+ years of experience in regulatory affairs and related fields.
Why pursue a certificate in regulatory affairs?
- R&D, manufacturing, quality and clinical personnel need to understand regulatory requirements that affect their responsibilities.
- Regulatory compliance is not just the responsibility of Regulatory Affairs.
- The program can be tailored to meet individual needs and responsibilities.
Our online Regulatory Affairs and Services program
The RAS certificate program is available to students nationally via a synchronous Adobe Connect Internet connection.
- Students connect synchronously to class and actively participate in lectures and discussions.
- All class sessions are recorded for those who might miss a lecture and for study purposes.
- The RAS program has three year of successful experience with remote learning via Adobe Connect.
Program Track
Fall Semester
- RAS-621 Legal Basis for Medical Product Regulation
- RAS-633 Quality Systems for Regulated Industry
Spring Semester
- General Medical Device Option
- MTQ-624 Risk management
- RAS-631 IDE Regulations and Clinical Trial Design
- RAS, ACR or MTQ elective selected with advisor approval
- US Regulatory Affairs Option
- RAS-623 Regulatory Routes to Market: 510(k)s
- RAS-631 IDE Regulations and Clinical Trial Design
- Regulatory Compliance Option
- RAS-635 Regulatory Affairs Compliance (spring semester)
- MTQ-634 Corrective and Preventive Actions (spring semester)
Summer Semester
- International Regulatory Affairs Option
- RAS-627 International Regulatory Affairs: European Union, Eastern Europe, Canada and Australia
- Regulatory Compliance Option
- MTQ- 638 Supplier Development and Management
Fall Semester
- US Regulatory Affairs Option
- RAS-625 Regulatory Routes to Market: PMAs
- International Regulatory Affairs Option
- RAS-655 International Regulatory Affairs: Japan, Other Asia, Latin America and Middle East
- RAS, ACR or MTQ elective selected with advisor approval
