Master's in Regulatory Affairs Online

The Master's in Regulatory Affairs at Technische Hochschule Lübeck is an online programme established in 2018 and delivered over four semesters, starting in the winter semester. It focuses on regulatory knowledge and strategy for medical devices, including in-vitro diagnostics, covering the medical, chemical, biological, toxicological, and clinical dimensions of technical documentation. The curriculum addresses national and European regulations as well as the medical device regulatory frameworks of key international markets including the USA, Japan, Canada, and China. Elective modules allow students to specialise in areas such as project management, entrepreneurship, or pharmaceutical law. The programme is based at the medical technology hub in Lübeck and builds directly on a prior professional Bachelor's degree. Admission requires either a first degree with 210 ECTS in an eligible field, or a degree with 180 ECTS under which students complete up to 30 additional ECTS credits alongside their Master's studies. At least one year of relevant professional experience after graduation is also required. The programme is offered at Technische Hochschule Lübeck in Lübeck, Germany.