Regulatory Affairs, M.Sc.
![['English'] Zitat zum Masterstudiengang Regulatory Affairs an der TH Lübeck](/fileadmin/_processed_/3/2/csm_fhl_studierende_innen_17_11_0004_web.jpg_34874e7542.jpg)
The insights into international efforts regarding medical device safety is truly impressive. The quality of the scripts and web tools is excellent. They convey regulatory topics in an exciting and practical manner.
Sven
Regulatory requirements for medical devices play an increasingly important role in the quality and safety concepts of medical products. The demand for professionally qualified experts to address regulatory issues in the field of medical devices using interdisciplinary scientific methods and strategies has been steadily increasing for years.
At the medical technology hub in Lübeck, the online Master's degree program "Regulatory Affairs," which was established in 2018, complements the existing range of studies in medical technology. Drawing on the extensive resources of the BioMedTec Science Campus, the program trains highly qualified experts to deal with regulatory issues in the field of medical devices, including in-vitro diagnostics, and to solve them using interdisciplinary scientific methods and strategies. Given the increasing importance of regulatory requirements in the quality and safety concepts for medical products, graduates have excellent career prospects.
For more information and the detailed course content, please refer to the module descriptions in the course overview.
As a special feature, interested students can acquire the "Quality Manager Junior" certificate from the University of Applied Sciences Lübeck as part of their studies.
Start of Winter Semester 2026/27
The next kick-off meeting for the start of studies in the Winter Semester 2026/27 is planned for September 25, 2026 (starting around 4 p.m.) and September 26, 2026 (9 a.m. - 3 p.m.) and will be held for the first time as a hybrid event in English. This means that new students can meet in person in Lübeck to get to know each other and network. All courses offered as part of the kick-off meeting will also be available remotely in English, allowing students who are not from Germany or who do not wish to travel a long distance to participate virtually.
You can apply online for the Master's program in Regulatory Affairs starting in the Winter Semester 2026/27 from May 1st until August 31st 2026 via the TH website. Outside of this period, please contact the admissions office. As an applicant with an international degree you apply via https://www.uni-assist.de/en/ - deadline will be here July 15th 2026.
APS certificates are mandatory for China, India, and Vietnam, and must usually be submitted before the application deadline.
Documents required:
- Bachelor or Diploma certificate
- Certificate of deregistration from your previous university
- Proof of employment
- Proof of English proficiency
- Additional documents may be required on a case-by-case basis.
Information on future courses:
Starting in the Winter Semester 2026/27, the MRA course will be offered entirely online, in English language, and from the first semester also for international students.
Program Overview
| Degree: | Master of Science, M.Sc. |
|---|---|
| Standard Period of Studies: | 4 Semesters |
| Start of Studies: | Each Winter Semester |
| Form of Studies: | Online |
| Admission Requirements: | The admission requirements for the Master's program in Regulatory Affairs are, with regard to the university degree: a) a first professional university degree with 210 ECTS credits in the field of engineering or natural sciences (e.g., physics, biology, chemistry), medicine, medical sciences, computer science, economics, or law or b) a first professional university degree with 180 ECTS credits in the field of engineering or natural sciences (e.g., physics, biology, chemistry), medicine, medical sciences, computer science, economics, or law. In case b), admission is conditional upon the student independently completing up to 30 ECTS credits of selected coursework alongside their Master's studies. The program head will determine which coursework is suitable and can be recognized. This coursework can be completed online or in person, for example, in the form of modules or courses. The required coursework can be offered by Lübeck University of Applied Sciences or by other universities and colleges within and outside of Germany, provided that the ECTS credits are awarded or are transferable to the German ECTS credit system. Further admission requirements are a final grade of the first university degree of at least 2.5, and one year of relevant professional experience after graduation. The fee for the online course is EUR 10,000 for four semesters. |
| Admission Restrictions: | 25 Study places. |
| Regulations: | study and examination regulations from ws 2026 onwards (PDF, GER) Studien- und Prüfungsordnung (PDF, GER) Prüfungsverfahrensordnung (PDF, GER) Confirmation of the submission of the Master's thesis (PDF) Exmatriculation (PDF) Information sheet for the preparation of Master's thesis (PDF) Information sheet on the acquisition of additional credits (PDF) Issue of a Master's Thesis (PDF) Master's thesis cover page (PDF) Recognition of professional experience (PDF) Registration for the oral final examination (PDF) Statutory declaration (PDF) Antrag auf Verlängerung der Regelstudienzeit (PDF, GER) |
In Brief – Regulatory Affairs
Regulatory Affairs encompasses all activities that ensure regulated products meet statutory requirements, can be safely brought to market, and remain continuously monitored. The primary focus is on medical devices and in vitro diagnostics (IVDs)—ranging from product approval and conformity assessment procedures to post-market surveillance. It also addresses adjacent healthcare sectors and borderline classification issues, such as those relating to the pharmaceutical industry. An in-depth exploration of regulatory aspects in pharmaceuticals is likewise possible. Furthermore, Regulatory Affairs covers the strategic concept, compilation, and submission of regulatory dossiers for new products, as well as compliance with current MDR/IVDR regulations and statutory requirements.
The Master’s program in Regulatory Affairs at TH Lübeck provides comprehensive expertise in regulatory requirements for medical devices and in vitro diagnostics throughout their entire product life cycle. Course content includes approval and conformity assessment procedures, quality management, clinical evaluation, and safety and vigilance systems across European and international markets. The program qualifies graduates for cross-functional interface positions in research & development (R&D) and quality assurance. Additionally, students learn to approach regulatory challenges from an interdisciplinary perspective and solve them using scientific methods and strategic approaches.
The program is demanding, but its part-time, fully online format makes it easy to schedule and manage. With 90 ECTS credits, it entails a moderate workload. Examinations take place during single-day on-campus sessions at TH Lübeck; otherwise, the degree program is conducted entirely online. This allows for flexible time management that can be easily balanced with professional and personal commitments. Proficiency in English is advantageous for navigating international standards and global markets.
The tuition fee for the online Master’s program in Regulatory Affairs is €10,000 for four semesters. Compared to private universities, studying at TH Lübeck is significantly more affordable. TH Lübeck’s online degree programs are accredited and equivalent in quality to on-campus programs. The degree awarded is a full Master’s degree that is recognized both in Germany and internationally.
There is no single career pathway; however, a sound qualification in regulatory requirements is essential. Typically, degrees in the natural sciences or engineering combined with a specialization in Regulatory Affairs lead into this field. The Master’s program in Regulatory Affairs at TH Lübeck provides targeted knowledge of medical device law, quality management, and approval procedures, preparing students for roles in medical technology companies, regulatory authorities, or Notified Bodies. With increasing professional experience, senior positions such as Head of Regulatory Affairs, responsible for an entire company’s regulatory strategy, become accessible. Professional development in Regulatory Affairs is in high demand, and the need for qualified specialists continues to grow due to increasingly stringent regulatory standards.
Contact
You have questions about the degree program? The following contacts are happy to help.
Head of Program
| Prof. Dr. sc. hum.
Dipl.-Chem.
Folker Spitzenberger M.D.R.A. | |
| Telefon: | +49 451 300 5372 |
| E-Mail: | folker.spitzenberger@th-luebeck.de |
| Raum: | G.1 13-2.54 |
Program Coordinator
| Silke Venker | |
| Telefon: | +49 451 300 5396 |
| E-Mail: | silke.venker@th-luebeck.de |
| Raum: | B.64.100.00.044.00 |
Admission Office
Do you have questions regarding application or enrolment?
Please contact our Admission Office.
Phone: +49 451 300 5644 (Service Point)
E-mail: studieren(at)th-luebeck.de
Room: A.1-0.50
