Master's in Regulatory Affairs Online Technische Hochschule Lübeck

The degree programme focuses on providing the regulatory knowledge and tools necessary to develop and implement an optimal regulatory strategy for medical devices, including in-vitro diagnostics.

Through hands-on training following the initial professional Bachelor's degree, students gain in-depth knowledge of the medical, chemical, biological, toxicological and clinical aspects of technical documentation for medical devices.

The programme covers not only national and European regulations, but also the intricacies of key international medical device markets such as the USA, Japan, Canada and China.

A wide range of elective modules allows you to specialise in areas such as project management, entrepreneurship, or pharmaceutical law.

At the medical technology hub in Lübeck, the online Master's degree programme in "Regulatory Affairs," which was established in 2018, complements the existing range of studies in medical technology.

In the third semester, students engage in a practical project to prepare for their future work environment in Regulatory Affairs.

During this project, students tackle and solve an initial regulatory issue that arises in the practical environment of a company or other stakeholders within the medical device system, e.g. a notified body, an authority or other relevant representatives.

This involves independent research and documentation of project topics proposed either by the student or by TH Lübeck or affiliated institutions. The practical project may involve on-site activities in companies in the medical device industry (including as part of regular employment, if appropriate), potentially preparing students for the Master's thesis.

The project culminates in a written project report, which is evaluated as part of the examination process.

The admission requirements for the Master's programme 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 programme head will determine which coursework is suitable and can be recognised. 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.

Per semester, students have to pay around 200 EUR for student organisation support.

The TH Lübeck has a career centre which supports with CV writing and company addresses.

This is not needed for international students, since the programme is fully online.