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Part Time - Assistant Academic Specialist - Regulatory Affairs - Medical Devices

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening.  To apply for the job, please click the Apply for this Job link.

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Northeastern University Employee Benefits

Northeastern University is an Equal Opportunity, Affirmative Action Educational Institution and Employer, Title IX University. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by the law. Northeastern University is an E-Verify Employer.

Posting Details

Position Information

Position Title Part Time - Assistant Academic Specialist - Regulatory Affairs - Medical Devices
Requisition Number PTFR000382
Division/College College of Professional Studies
Interdisciplinary Division/College
Location Boston Main Campus
Full-Time/Part-Time Part Time
Benefits Eligible
Posting Date 06/26/2017

Northeastern University’s College of Professional Studies (CPS) invites applications for a half-time, non-tenured track Assistant Academic Specialist annually renewable faculty position for the Graduate Programs in Regulatory Affairs for Drugs, Biologics, and Medical Devices. The successful applicant will teach on-campus and online graduate-level courses within the Regulatory Affairs Program. Instructional areas will focus on the global regulatory aspects of medical device product commercialization from US and international perspectives. In addition, the successful applicant will serve as a subject matter expert (SME) in the following areas:

• Regulation of the product life cycles for medical devices from design through marketing clearance/approval and subsequent product obsolescence
• Establishment registrations, 510(k) premarket notifications, Premarket Approvals (PMA), CE marks and other global regulatory submission requirements for medical device marketing
• Quality Management System (QMS) 21 CFR Part 820 setup and compliance in the US and similar requirements in the EU and other major geographic markets
• Medical Device Reporting (MDR) requirements, product complaint handling, product recalls and other medical device post-market regulatory compliance requirements

The ideal candidate will have the expertise & capability to teach in other areas of the Life Sciences domain within CPS including Biotechnology and/or Health Sciences.

This position is not benefits eligible.

The Graduate Programs in Regulatory Affairs for Drugs, Biologics, and Medical Devices at CPS currently consist of 4 distinct Certificate Programs in addition to a Master of Science Degree (MSRA) Program. These Programs were among the first graduate level Regulatory Affairs Programs developed in the US and internationally, and hold the number one global market share position in this area. The broad nature of the Program curriculum, combined with the diversity of its student population and the unparalleled opportunity for students to engage in experientially based-learning are among the factors that differentiate CPS’s Graduate Regulatory Affairs Programs from other graduate regulatory affairs programs.

Each of the Regulatory Affairs Certificate Programs as well as the MSRA program can be earned either through on-ground or online coursework. For a full list of courses and the curriculum, click on the “curriculum tab” of the following link:

Courses are offered in on campus, online and blended formats and are typically 12-weeks in duration, with a few each year held as 6-week intensives. The majority of courses begin in September, January, April, and July.

About the Position

The Assistant Academic Specialist is based in Boston, Massachusetts; however, there is a possibility of traveling once or twice a year to our satellite campuses (the College would cover travel and lodging costs). Courses are taught in multiple formats including online, blended and fully on ground in Boston; faculty do have the opportunity for a home office and are not required to be in Boston every day of the week. Faculty enjoy a collegial work environment that allows for work-life balance, and are expected to be available to students, whether in-person or online. Opportunities exist for additional compensation through other non-teaching activities. Faculty contribute to the College’s mission through teaching, service and scholarship. The Faculty member will work closely with other program faculty, and report directly to the Associate Dean for Graduate Academic and Faculty Affairs. The unique half-time nature of this position will allow the incumbent to make an impact on the field of regulatory affairs through the training of new and existing regulatory professionals as well as the opportunity to provide academic leadership to the program, while still maintaining their industry involvement. Our courses are designed for working professionals and take place in the evening or online. This coupled with the half-time nature of the position will enable the incumbent to maintain their ‘day job’ should they desire.


Required Qualifications:
• MS (or equivalent) in life sciences or related disciplines
RAC Certification
• At least 7 years of professional Regulatory Affairs and or Clinical Affairs experience within life science industry

Preferred Qualifications:

• Two years of teaching at the graduate level
• Experience with international students
• Experience in curriculum development
• Demonstrated leadership skills
• Demonstrated communication skills, both oral and written
• Demonstrated problem-solving and interpersonal skills
• Ability to work collaboratively with others
• Demonstrated ability to innovate
• Ability to successfully advocate for new academic initiatives and motivate others to embrace them

Additional Information

Northeastern University is a global, experiential and leading research university, built on a tradition of engagement with business, industry and communities to create a distinctive approach to education, research and service. Boston is vibrant and stimulating and provides exciting opportunities to grow, learn and to make significant contributions. CPS’s Graduate Regulatory Affairs Programs are fully aligned with Northeastern University’s Professional Advancement Network (PAN), which is designed to help students develop a foundation for professional growth and success. The Professional Advancement Network offers innovative and flexible programs that allow adult learners and working professionals to complete their degrees. PAN offers associate, bachelor’s degree, certificate programs and post-baccalaureate programs in fast-growing fields such as biotechnology, leadership, business administration, finance, project management, information technology and management. Degrees are delivered in full or part-time formats and courses are offered in a variety of on-campus and online options.

Documents Needed to Apply

Required Documents
  1. Curriculum Vitae
  2. Cover Letter
Optional Documents
  1. Resume
  2. Other
  3. References

Posting Specific Questions

Required fields are indicated with an asterisk (*).