Online Master of Science in Regulatory Affairs
Specialise in medical device and in-vitro diagnostics regulation with a fully online, internationally recognised degree.
Best for:Best for professionals with a Bachelor’s degree in engineering, natural sciences, medicine, computer science, economics, or law, seeking to specialise in regulatory affairs for medical devices and diagnostics with a flexible, online study format.
Overview
The Master of Science in Regulatory Affairs at Technische Hochschule Lübeck is a fully online programme designed for professionals seeking expertise in regulatory strategies for medical devices and diagnostics. Located in Lübeck, a hub for medical technology, this programme equips graduates with in-depth knowledge of medical, chemical, biological, and clinical documentation requirements, as well as international regulations in markets like the USA, Japan, and China. Students engage in hands-on training, including a practical project in the third semester, and can specialise in areas such as project management, entrepreneurship, or pharmaceutical law. The programme is ideal for those aiming to advance their careers in regulatory affairs within the medical device industry or related sectors.
What you'll do
- Develop and implement regulatory strategies for medical devices and in-vitro diagnostics.
- Gain in-depth knowledge of medical, chemical, biological, toxicological, and clinical documentation requirements.
- Engage in hands-on training through practical projects, including independent research and documentation.
- Complete a third-semester project addressing real-world regulatory issues in collaboration with industry partners.
- Specialize in elective modules such as project management, entrepreneurship, or pharmaceutical law.
- Prepare and submit a written project report evaluated as part of the examination process.
Requirements
Degree required: A first professional university degree (Bachelor’s) with either 210 ECTS credits or 180 ECTS credits in engineering, natural sciences (e.g., physics, biology, chemistry), medicine, medical sciences, computer science, economics, or law. Applicants with 180 ECTS may need to complete up to 30 additional ECTS credits alongside the Master’s programme.
Degree offered: Master of Science
Language: English proficiency at B2 level (e.g., IELTS Academic score of 6 or equivalent).
Instruction: English
- Proven academic background in engineering, natural sciences, medicine, computer science, economics, or law.
- At least one year of relevant professional experience after graduation.
- Basic proficiency in English for academic study (B2 level).
- Ability to complete independent research and documentation for practical projects.
- Final grade of the first university degree must be at least 2.5 (on a scale where 1.0 is the highest).
- No German language skills required.
- Open to applicants from EU and non-EU countries.
Funding & terms
Programme and admissions
Admissions not verified
A catalogue listing does not mean applications are open or funding is guaranteed. Check the source for your intake.
- Intake
- Not confirmed by the source
- Duration
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- Teaching language
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- Taught / research mode
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- Study mode
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- Campus
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- Prerequisites
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- Tuition
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- Funding
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How to apply
Deadline: 2027-07-15
Applicants must submit their application through uni-assist or via email to silke.venker@th-luebeck.de. The application should include all required documents, such as academic transcripts, proof of English proficiency, and a CV. Detailed instructions and deadlines are available on the programme’s official website.
- CV
- Proof of English proficiency (B2 level, e.g., IELTS Academic score of 6)
- Official transcripts of the first university degree (Bachelor’s)
- Proof of relevant professional experience (if applicable)
- Letter of motivation (if required)
- Passport or ID copy
Contact
Silke Venker· Programme Coordinator
https://www.th-luebeck.de/studium/studienangebot/studiengaenge/regulatory-affairs-msc/uebersicht/
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