Master's
MSc Medical Device Regulatory Affairs – WIT
Course Overview
The MSc Medical Device Regulatory Affairs prepares graduates to manage the regulatory approval and compliance processes for medical technologies within international healthcare markets. Students study global medical device regulations, quality management systems, clinical evaluation, risk management, product lifecycle management, and regulatory strategy through industry-focused learning and practical case studies.
The programme develops expertise in ensuring medical devices meet international safety, quality, and legal requirements. Students strengthen analytical, documentation, and project management skills relevant to regulated healthcare industries. Graduates are prepared for careers in medical device companies, regulatory affairs, quality assurance, compliance, and healthcare technology.
Entry Requirements
- Certified copy of a recognized Level 8 bachelor’s degree in Engineering, Life Sciences, Pharmacy, or Technology (minimum 55% or 3.0 GPA).
- IELTS 6.5 (with no band less than 6.0), TOEFL iBT 88, PTE 58, or Duolingo 115.
- Technical background evaluation in medtech design, regulatory frameworks, or quality management.
- Professional CV/resume, certified university transcripts, statement of purpose, and two LORs.
- Medical device industry background review or online faculty interview.
Career Outcomes
- Regulatory Affairs Specialist
- Medical Device Compliance Officer
- Quality Assurance Specialist
- Regulatory Consultant
- Clinical Evaluation Specialist
Scholarship Available
- Yes (SETU Postgraduate Scholarships)
