PT Lecturer - Regulatory Affairs - Medical Devices
About Northeastern: Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
Our locationsin Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahantare nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.
Northeastern's comprehensive array of undergraduate and graduate programs in a variety of on-campus and online formatslead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.
About the Opportunity: Looking for a qualified candidate who would teach on-ground, hybrid, and online graduate-level courses on Regulatory Affairs. This position is located at the Northeastern University Boston Campus.
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.
Preferred Qualifications: N/A
Salary Grade: FAC
Additional Information: This is a part-time, non-benefits eligible, non-tenure track renewable position. Courses are offered in online, on-campus, and blended formats. Courses are typically 12-weeks in duration (8 weeks in the summer) with a few each year held as 6-week intensives. The majority of classes begin in September, January, April, and July. Positions are available contingent upon enrollment, funding, and departmental needs. Stipend rates per course.
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.