Program Overview

Master of Science in Regulatory Affairs – Medical Devices

Overview

The Master of Science in Regulatory Affairs – Medical Devices is a full-time program offered by SRH University. The program focuses on the regulatory requirements for medical devices, ensuring compliance with national, European, and international standards, laws, and regulations.

Program Details

• Degree: Master of Science (M.Sc.)
• Start: Summer and winter semester
• Model: Full-time
• Language: English
• ECTS: 120
• Info: In accreditation
• Duration: 4 semesters
• Location: Fürth
• Costs: From €750 per month

Study Contents

The program covers key areas such as quality management systems, international approval processes, and risk management. Students will gain hands-on expertise in post-market surveillance, health economics in market access, and the application of artificial intelligence (AI) in regulatory affairs.

Career Opportunities

A Master's in Regulatory Affairs opens up a wide range of career opportunities in medical technology, the pharmaceutical industry, and regulatory agencies. Typical career paths include:

• Regulatory Affairs Manager for medical devices & pharmaceuticals
• Auditor or product expert for medical technology
• Quality or Compliance Manager in the healthcare industry
• Consultant for regulatory affairs & market strategy
• Project Manager for product approval & market entry
• Regulatory agency or certification body specialist
• Expert in post-market surveillance & risk management

Admission Requirements

To apply for the Master's degree Regulatory Affairs – Medical Devices, you need:

• Graduated first degree, such as Bachelor or Diploma with a scope of at least 180 ECTS
• The degree should be in Medical Technology, Industrial Engineering, Information Systems, (Health) Economics, Medicine, Pharmacy or a similar area of studies and be issued by an accredited university
• Proof of English proficiency: IELTS 6.5

Application Process

1. Apply online via the SRH application portal
2. If you fulfill the admission requirements, we will invite you to a selection interview
3. If the interview is successful, you will receive a letter of acceptance and a study contract from us
4. You sign the study contract and send it back to us
5. You pay the enrolment fee
6. We will send you your letter of admission
7. You take part in our induction week and then you're ready to go!

Tuition Fees

• Citizenship | EU/EEA (incl. Western Balkans, Switzerland and Ukraine): €750 / month
• Citizenship | non-EU/EEA: 850 € / semester

A one-off registration fee of € 750 (EU/EEA) / € 1,000 (non-EU/EEA) is charged. With the exception of any placement, aptitude or equivalency tests, no separate examination fees or similar are charged, not even for repeat examinations.