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Medical Devices Regulatory Affairs logo
Northeastern University logo

Medical Devices Regulatory Affairs

Northeastern University
Tuition USD 10,624 (Tuition (Full programme)) — International students; USD 10,624 (Tuition (Full programme)) — National students
Degree Postgraduate Certificate
Delivery Online
Location Boston, United States
Language English

Program Overview

The Medical Devices Regulatory Affairs at Northeastern University is a Postgraduate Certificate programme in Humanities, delivered Online. This programme equips graduates with advanced knowledge and practical skills for professional and academic careers in the field.

Students gain a rigorous grounding in both the theoretical foundations and applied dimensions of humanities. The programme combines coursework, research components, and practical projects that develop critical thinking, problem-solving, and specialist expertise relevant to industry and research needs.

Graduates of the Medical Devices Regulatory Affairs programme are well-prepared for careers in academia, industry, government, and the private sector across United States and internationally. The programme provides an internationally recognised qualification within the Bologna higher education framework.

Key Program Features

  1. Language of instruction: English
  2. Study mode: Online
  3. English requirement: IELTS 6.5
  4. Tuition: USD 10,624 (Tuition (Full programme)) — International students; USD 10,624 (Tuition (Full programme)) — National students

Career Opportunities

Graduates of the Medical Devices Regulatory Affairs programme are prepared for diverse careers in humanities:

  1. Researcher / Academic
  2. Cultural Programme Manager
  3. Editor / Writer
  4. Translator / Interpreter
  5. Museum Curator
  6. Communications Specialist

Program Curriculum

Course Structure

  1. Medical Device Development, A Regulatory Overview
  2. Emerging Trends and Issues in the Medical Device Industry
  3. The Business of Medicine and Biotechnology
  4. Combination Products and Convergence
  5. Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing
  6. Global Awareness: European Medical Device Regulations
  7. Japanese Medical Device Regulations and Registrations
  8. Canadian and Australian Medical Device Regulations
  9. Global Awareness: Emerging Medical Device Markets
  10. Food, Drug, and Medical Device Law: Topics & Cases
  11. Regulatory Writing: Medical Device Submissions
  12. Technology Licensing

Admission Requirements

Academic Requirements

  • Online application
  • Statement of purpose (500-1000 words): identifying your educational goals and expectations from the program; please be aware that the University\'s academic policy on plagiarism applies to applicant\'s statement of purpose
  • Professional resume: Current resume that displays job responsibilities, relevant experience, and education history
  • Official undergraduate degree documentation
  • Proof of English language proficiency: ONLY for students for whom English is not their primary language: English language proficiency guidelines

English Proficiency: IELTS 6.5 or equivalent.

Tuition & Financial Information

Tuition Fee

USD 10,624 (Tuition (Full programme)) — International students; USD 10,624 (Tuition (Full programme)) — National students

Tuition fees: USD 10,624 (Tuition (Full programme)) — International students; USD 10,624 (Tuition (Full programme)) — National students

IELTS requirement: 6.5

Financial Aid & Scholarships

Contact Northeastern University directly for scholarship, grant, and financial aid information for this programme. Many European universities offer merit-based and need-based funding for international and domestic students.

About Northeastern University

Northeastern University logo

Northeastern University

Boston, United States

Northeastern University is a distinguished institution of higher education committed to academic excellence, innovative research, and preparing students for leadership in their chosen fields. The...

University Profile
  • Start Date 2017-10-01
  • Language English