Graduate Certificate in Medical Device Regulatory Affairs — Boston
The Graduate Certificate in Medical Device Regulatory Affairs provides an in-depth knowledge of the regulations and standards, global applications, and social impact of the medical device industry.
Take a quick look
We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.
01
Customize your plan
We work with you to map your path to your goal.
02
Learn from experience
From real-world case studies to employer-based projects, we prepare you to manage what comes next.
03
Choose your focus
Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.
04
Study anywhere, on your time
Part-time or full-time, we move at your speed, to get you where you’re going.
Overview
The medical device industry has continued to experience healthy market growth despite the sluggishness of the national economy. In fact, the industry's support of research and development efforts is expected to top $194 billion this year. There are over 7,000 medical device companies in the United States, and nearly 1,000 of these are based in Massachusetts. In total, the medical device sector in Massachusetts employs 36,000 workers, has a payroll of over $1.8 billion, and annual shipments of $7.3 billion.
The Graduate Certificate in Medical Device Regulatory Affairs provides an in-depth knowledge of the regulations and standards that apply to the development of medical devices, including those products not specifically regulated by federal law. The program will review the global applications of the medical device industry. Students will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S. The program also focuses on the social and financial impact of the medical devices industry on the aging population.
More Details
Unique Features
- Boston location on flagship campus—a hub for healthcare, education, finance, business, biotechnology, and the life sciences
- Choose from elective courses that cover a broad range of practical and relevant issues in the field
- Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs
Experiential / Co-op opportunities
Northeastern's signature experience-powered learning model has been at the heart of the university for more than a century. It combines world-class academics with professional practice, allowing you to acquire relevant, real-world skills you can immediately put into action in your current workplace.
This makes a Northeastern education a dynamic, transformative experience, giving you countless opportunities to grow as a professional and person.
Get Set with a Custom Course Plan
General Requirements
Required Courses
| 2.00 | ||
| 4.00 |
Electives
Complete the appropriate number of electives to obtain minimum quarter hours required for the program:
| 2.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 2.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 | ||
| 4.00 |
Now Let's Talk Admissions
You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.
Application Requirements
- Online application
- Statement of purpose (500–1000 words): identify your educational goals and expectations of the program; please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose
- Professional resumé
- Unofficial undergraduate transcripts (official transcripts required at the time of admission)
- English language proficiency proof: students for whom English is not their primary language must submit one of the following:
- Official associate or bachelor's degree transcript from an accredited college or university in the U.S, stating degree conferral and date
- TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores
International Requirements
Are You an International Student? Find out what additional documents are required to apply.
Global Engagement Learn how our teaching and research benefit from a worldwide network of students, faculty, and industry partners.
Financing Requirements
Finance Your Education We offer a variety of resources, including scholarships and assistantships.
How to Apply Learn more about the application process and requirements.
Cost and Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2020-2021 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. For more detailed information, please visit Student Financial Services.
Application Deadlines
Our admissions process operates on a rolling basis; however, we do recommend following the application guidelines below to ensure you can begin during your desired start term.
Spring 2021
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: April 12, 2021) | February 8, 2021 |
| International in-country application complete (start date: April 12, 2021) | March 8, 2021 |
| Domestic application complete (first half start: April 12, 2021) | April 2, 2021 |
| Domestic application complete (second half start: May 24, 2021) | May 14, 2021 |
Summer 2021
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: July 12, 2021) | May 10, 2021 |
| International in-country application complete (start date: July 12, 2021) | June 14, 2021 |
| Domestic application complete (first half start: July 12, 2021) | June 28, 2021 |
| Domestic application complete (second half start: August 9, 2021) | July 26, 2021 |
Fall 2021
| Recommended Admissions Deadline: | |
|---|---|
| International out-of-country application complete (start date: September 20, 2021) | July 19, 2021 |
| International in-country application complete (start date: September 20, 2021) | August 23, 2021 |
| Domestic application complete (first half start: September 20, 2021) | September 7, 2021 |
| Domestic application complete (second half start: November 1, 2021) | October 18, 2021 |
Winter 2022
| Recommended Admissions Deadline | |
|---|---|
| International out-of-country application complete (start date: January 10, 2022) | November 8, 2021 |
| International in-country application complete (start date: January 10, 2022) | December 13, 2021 |
| Domestic application complete (first half start: January 10, 2022) | December 20, 2021 |
| Domestic application complete (second half start: February 22, 2022) | February 8, 2022 |
Spring 2022
| Recommended Admissions Deadline | |
|---|---|
| International out-of-country application complete (start date: April 11, 2022) | February 7, 2022 |
| International in-country application complete (start date: April 11, 2022) | March 14, 2022 |
| Domestic application complete (first half start: April 11, 2022) | March 28, 2022 |
| Domestic application complete (second half start: May 23, 2022) | May 9, 2022 |
Summer 2022
| Recommended Admissions Deadline | |
|---|---|
| International out-of-country application complete (start date: July 11, 2022) | May 9, 2022 |
| International in-country application complete (start date: July 11, 2022) | June 13, 2022 |
| Domestic application complete (first half start: July 11, 2022) | June 27, 2022 |
| Domestic application complete (second half start: August 8, 2022) | July 25, 2022 |
Student Body Profile
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
-
Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
-
What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
-
What They're Skilled At
- Regulatory Affairs
- Pharmaceutical Industry
- U.S. Food and Drug Administration
- Clinical Trials
- Standard Operating Procedure (SOP)
Learn more about Northeastern Alumni on Linkedin.