Program Overview

Introduction to the MAS in Regulatory Affairs and Quality Management

The MAS in Regulatory Affairs and Quality Management is a program offered by the School for Translational Medicine and Biomedical Entrepreneurship (sitem-insel School) at the University of Bern. Regulatory specialists play a crucial role in bringing novel medical devices to market, requiring a broad range of managerial, interpersonal, technical, clinical, and legal skills. This program provides career-specialized training in Regulatory Affairs, Quality Management, and Advanced Regulatory Affairs, with a focus on European Medical Device Regulations.

Program Details

• Degree: Master of Advanced Studies in Regulatory Affairs and Quality Management (MAS RAQM)
• Start: 2026
• Length: 4 semesters
• Scope: 60 ECTS
• Cycle: Annual
• Flexible entry: Yes
• Single module visitable: Yes
• Location: sitem-insel, Freiburgstrasse 3, 3010 Bern, Switzerland
• Language: English
• Admission requirements: Minimum Bachelor's degree from a university or university of applied sciences in natural sciences, engineering, medicine, pharmacy, or law. Professional experience is not mandatory.
• Registration deadline: July 15, 2026
• Cost: CHF 31,500
• Special offer: Available upon request

About the Program

The program is designed for graduates interested in commencing a career in regulatory affairs or quality management within medical device companies or regulatory bodies. It also targets mid-level experienced professionals seeking to enhance their proficiency and approach different career options. Additionally, it caters to those from complementary disciplines such as entrepreneurship, research and development, and management, who are looking for comprehensive and practical knowledge in the regulation of medical devices according to the new European MDR or quality management of such products.

What to Expect from the Program

• Increase career prospects
• Obtain an internationally recognized degree from a prestigious Swiss university
• Gain expert insights from academia and industry
• Connect and exchange with peers and lecturers
• Acquire extensive knowledge and skills development in relevant topics
• Keep up with the latest regulatory changes and implementations
• Pursue a "Master of Advanced Studies" title in a stepwise approach
• Benefit from small class sizes and flexibility of study formats

Program Structure

The program has a modular structure, allowing participants to pursue their goals tailored to their needs. It starts with a Certificate of Advanced Studies (CAS) in Regulatory Affairs, Quality Management, or Advanced Regulatory Affairs, which can be gradually built up to a Master of Advanced Studies in Regulatory Affairs and Quality Management (60 ECTS) over time. Each CAS corresponds to at least 15 ECTS credits, earned by completing at least three modules. The program is conceptualized as an extra-occupational program that can be reconciled with professional work.

Modules

The program includes various modules:

Regulatory Affairs

• RA1: Introduction to Regulatory Affairs
• RA2: Pre-Submission Regulatory Affairs
• RA3: Post-Submission Regulatory Affairs

Quality Management

• QM1: Introduction to Quality Management
• QM2: Design Control: from input to validation
• QM3: Risk Management and Usability Engineering

Advanced Regulatory Affairs

• ARA1: ATMP Regulatory Affairs
• ARA2: Combination Products
• ARA3: FDA & Foreign Regulatory Affairs
• ARA4: Medical Device Clinical Evaluation
• ARA5: AI & Digital Health Technologies

Internship/Professional Experience

Participants without prior professional experience in a relevant field must complete an internship related to regulatory affairs and/or quality management in translational medicine as part of their studies. The minimum duration of such an internship is 8 weeks based on full-time employment. The organization of the internship is the responsibility of the participant.

Organising Institution and Faculty

The program is offered by the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel), located on the Insel Campus Bern, and benefits from its proximity to Switzerland's largest university hospital (Inselspital) and the University of Bern. The Medical Faculty of the University of Bern is known for its excellent curriculum in human and dental medicine and offers an attractive range of training and continuing education in the field of health and medicine.

Admission, Fees, and Installments

Admission Requirements

Applicants must hold at least a Bachelor's degree from a university or university of applied sciences in the fields of natural sciences, engineering, medicine, pharmacy, or law. Professional experience is not mandatory.

Admission Process

Applications are submitted via the registration form, including all required attachments. The study commission may define further conditions for applicants without prior academic degrees or professional experience.

Tuition Fees & Installments

• Master of Advanced Studies (MAS): CHF 31,500
• Diploma of Advanced Studies (DAS): CHF 23,100
• Certificate of Advanced Studies (CAS): CHF 12,600 The full study fee can be paid in full at once or in installments per semester.