RGA

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.

Enrollment

Part-Time

Entry Terms

Fall, Spring, Summer, Winter

Completion Time

6-12 months

F1 Visa Eligible

Yes

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

Get Set with a Custom Course Plan

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.

  • 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

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.

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

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.