Part Time Lecturer - Regulatory Affairs - Medical Devices

About the Opportunity

Responsibilities:

Individual would teach on-campus (preferred) or online graduate-level courses for the Master of Science Degree in Regulatory Affairs of Drugs, Biologics, and Medical Devices and/or graduate certificate programs in Medical Device Regulatory Affairs. Instructional areas will focus on regulatory aspects of the medical device product commercialization lifecycle from US and international perspectives. These could include, but are not limited to, key provisions of the US Food and Drug Administration's (FDA's) risk-based medical device classification scheme, such as the premarket notification (510(k)), device pre-market approval (PMA), and investigational device exemption (IDE) submission processes. Additional areas of instruction may include regulation of combination products, quality systems regulations (QSR), regulator imposed post-market clearance/approval conditions, provisions of MDUFA III, FDAAA, FDASIA and other regulatory legislation, as well as the structure and function of non-US regulatory agencies.

Qualifications:

Candidates must have a Master of Science in a related field (doctorate strongly preferred) plus at least five years of industry or governmental experience. A history of successful teaching at the graduate level is strongly preferred. On-ground candidates must be able to commit to teaching on campus in Boston at least one night a week for an entire academic quarter (see below).

RAC Certification required for teaching courses offered to North Carolina, strongly recommended for other locations.

Diversity Statement:
The diversity, or inclusion, statement is required. Although there are no set rules, please write in the first person and use specific examples from your own personal experience. The statement should not exceed two pages.

Position Type

Academic

Additional Information

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.


To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Part-Time-Lecturer---Regulatory-Affairs---Medical-Devices_R102770







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