The Graduate Certificate in Medical Devices Regulatory Affairs provides an in-depth knowledge of the regulations and standards, global applications, and social impact of the medical device industry.
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 Devices 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.
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
Statement of purpose (500–1000 words): identifies your educational goals and expectations from the program; please be aware that the University's academic policy on plagiarism applies to your statement of purpose
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
RGA 6225 - Japanese Medical Device Regulations and Registration
RGA 6226 - Canadian and Australian Medical Device Regulations
RGA 6227 - Emerging Medical Device Markets
RGA 6203 - Food, Drug, and Medical Device Law: Topics and Cases
RGA 6370 - Regulatory Writing: Medical Device Submissions
RGA 6205 - Emerging Trends and Issues in the Medical Device Industry
Northeastern's signature experiential learning model combines academics with professional practice to help students acquire relevant, real-world skills they can apply to their desired industry. Each program offers its own unique experiential learning opportunities, but they might include:
Experiential Learning at Work — Working professionals collaborate with their employer to develop a project that addresses a key business need their company has in an area they want familiarity with.
Experiential Network (XN) — Students work virtually with a sponsoring organization on a short-term project over a six-week period.
Full-Time Co-op Opportunities — Students on co-op work in a paid position in their field of study for three to six months.
Our faculty represents a wide cross-section of professional practices and in fields ranging from finance to education to biomedical science to management to the U.S. military. They serve as mentors and advisors, and collaborate alongside students to solve the most pressing global challenges facing established and emerging markets.
Head of Regulatory Services, Professor and Advisor in Regulatory Affairs, Reimbursement, Pricing and Health Economics
By enrolling in Northeastern, you gain access to a network of more than 245,000 alumni and 3,200+ employer partners, including Fortune 500 companies, government agencies, and global NGOs. Our current students and faculty across strategically located regional campuses further foster that lifelong global community of learning and mentoring.
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.