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.
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Overview
Northeastern’s 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.
Through a targeted curriculum, this certificate program reviews the global applications of the medical device industry. You and your classmates will conduct practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S. This program also features insights on the social and financial impact of the medical devices industry on an aging population.
The certificate will help advance the careers of students coming from such fields as bioengineering, quality control/assurance, intellectual property, business, and marketing. Courses are selected to make this certificate ideal for students already working in the regulatory world or those just entering the profession.
Program objectives
- Familiarity with the regulations and standards that apply to the development of medical devices, within the US and globally
- To conduct a practical, in-depth analysis on how emerging developments and trends are reshaping medical devices regulation in the U.S.
- Understand the social and financial impact of the medical devices industry on the aging population.
Unique Features
- Classes available online or at the Boston campus for maximum flexibility
- Choose from elective courses that cover a broad range of practical and relevant issues in the medical device field
- Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs
Career Prospects
Beginning your journey with us is a big decision. But it's a smart one. Your field is evolving rapidly. That's why we're constantly innovating our programs to anticipate your industry's needs. So, no matter where your field goes, you can lead the way.
Average Salary, Compliance Officer
Average Salary, Project Management Specialist
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
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
Distinguished Faculty
"Northeastern is a world-class university with a tremendous trajectory. It's a wonderful institution where faculty can make a significant impact."
— Assistant Professor Stratis Ioannidis
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Stephen Amato
Global Regulatory Affairs, Market Access and Life Sciences Executive & Education AdministratorFull bio
Cost and Tuition
Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2024-2025 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. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.
For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.
Application Deadlines
Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:
Domestic Application Guidelines
International Application Guidelines*
*International deadlines are only applicable if the program is F1 compliant.
Did you know?
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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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.
Related Programs
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