Overview

The Regulatory Affairs and Services programme at Saint Cloud State University is designed to equip professionals with the leadership skills required for the global medical device industry. This curriculum focuses on the complex regulatory competency needed to manage approval processes and commercialise healthcare products.

Students gain deep insights into clinical affairs, quality systems, and healthcare reimbursement strategies. The teaching approach combines theoretical knowledge with practical applications, ensuring graduates are prepared for high-demand roles in the MedTech sector. The programme is delivered by faculty members who are active industry experts with extensive real-world experience.

Why Regulatory Affairs and Services at Saint Cloud State University?

This programme stands out as the only regulatory course in the United States specifically dedicated to the medical device sector. Students benefit from a curriculum informed by a senior executive advisory council, ensuring the content remains aligned with current industry requirements and technological advancements.

The university hosts the largest annual MedTech networking and job fair, featuring between 15 and 20 leading industry companies. This event provides students with unparalleled access to potential employers and professional networking opportunities. Additionally, the programme is one of only three in the nation selected to distribute prestigious industry scholarships.

Tuition Fee Breakdown

International fee: USD 19822 per year
National fee: USD 10146 per year
Local fee: USD 10146 per year

Visit the Fees and Funding section for a breakdown in your local currency.

Syllabus

Modules may include:

Regulatory Affairs
Clinical Affairs
Quality Systems
Health Care Reimbursement

Careers with Regulatory Affairs and Services

Graduates are prepared for leadership roles within the medical device industry, focusing on the commercialisation of products in global markets. The programme specifically targets the high demand for experts who can navigate the regulatory approval process for medical technologies.

Programme Structure

Courses included:

Legal Basis for Medical Device Product Regulation

Quality Systems for Regulated Industries

Regulatory Routes to Market: 510(k)s

IDE Regulations and Clinical Trial Design

Intl Regulatory Affairs: European Union, East Europe, Australia & Canada

Key information

Duration

Full-time
- 12 months

Start dates & application deadlines

Starting 2026-08-26 00:00:00
- Apply before 2026-08-01 00:00:00 , National
Starting 2027-01-13 00:00:00
- Apply before 2026-12-01 00:00:00 , National
- Apply before 2026-10-15 00:00:00 , International
Starting 2027-08-26 00:00:00
- Apply before 2027-06-15 00:00:00 , International

Language

English

Duolingo English Test

105

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TOEFL^® IBT

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IELTS

6.5

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Credits

33 SCH

33-36

Delivered

On Campus, Online

Campus Location

Saint Cloud, United States

Disciplines

Risk Management Operations and Quality Management View 53 other Masters in Operations and Quality Management in United States

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Academic requirements

GPA

2.7

English requirements

Duolingo English Test

105

Take A Free Practice Test!

TOEFL^® IBT

Schedule TOEFL®

IELTS

6.5

Prepare for Your English Test

Cathoven AI IELTS Preparation

Learn your IELTS Score

AI-powered IELTS feedback. Clear, actionable, and tailored to boost your writing & speaking score. No credit card or upfront payment required.

Trusted by 300k learners
98 accuracy using real exam data
4.9/5 student rating

Other requirements

General requirements

Upload unofficial transcripts.

Upload all required documents, including a customized Statement of Intent, Resume of educational and professional skills and experience, writing samples, and other required documents prescribed under program-specific admission policy.

Upload your statement of intent, resume, and a writing sample (if required).

Applicants may also submit unofficial copies of GRE/GMAT scores, TOEFL/IELTS/PTE and International transcript evaluations (if required) for the review process.

If admitted, you will need to submit official documents before coursework commences.

Tuition Fees

Tuition fees are shown in and the most likely applicable fee is shown based on your nationality.

International Applies to you

Applies to you

Non-residents

19822 USD / year

≈ 19822 USD / year
Out-of-State

10146 USD / year

≈ 10146 USD / year
Domestic

Applies to you

In-State

10146 USD / year

≈ 10146 USD / year

Living costs

Saint Cloud

United States

900 - 1400 USD / month

The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.

Funding

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

Win a €10000 Scholarship! Deadline: 30 June 2020

Embark on your journey with the Studyportals Scholarship! We're giving away a total of 20,000 euros to help you achieve your dream of studying abroad.

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Scholarships Information

Below you will find Master's scholarship opportunities for Regulatory Affairs and Services.

Available Scholarships

You are eligible to apply for these scholarships but a selection process will still be applied by the provider.

On this page

About

Overview

Programme Structure

Key information

Duration

Start dates & application deadlines

Language

Prepare for Your English Test

Credits

Delivered

Campus Location

Disciplines

What students do after studying

Academic requirements

English requirements

Prepare for Your English Test

Other requirements

General requirements

Tuition Fees

International Applies to you

Domestic

Living costs

Saint Cloud

Funding

Need help with your student visa?

Scholarships Information

Available Scholarships

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