Regulatory Affairs Specialist@ Universität zu Lübeck
Germany
Nilay Shah
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Universität zu Lübeck
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FlashIntel GPTNilay Shah is a highly skilled professional with 5 years of experience in regulatory affairs, python, autocad, unity, and english. Based in Germany, she has completed her master's course in Biomedical Engineering and has worked with various documents during her internship. Nilay has also developed expertise in technical documentation architecture and risk management standards. She is currently pursuing a master's degree in Biomedical Engineering and is open to discussing medical technologies and how medical devices can gain market access.
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About
I have completed my master’s course in Biomedical Engineering at Technische Hochschule Lübeck, Germany (with current CGPA of 1.3) and looking forward to working in the field of regulatory affairs. I had previously worked with MDSAP, ISO 13485: 2016, RDC 16 (Brazil), 21 CFR 820.30 (USA) documents during my internship. As a part of master thesis project work, I have worked on the design and implementation of a novel technical documentation architecture according to IVDR and to the new risk management standard (ISO 14971:2019) with special focus on performance evaluation, post-market surveillance and UDI system. As a student research assistant, I have worked with an electromagnetic tracking system, HoloLens, C-arm, 2D-3D registration, as well as optical tracking system in the Robotics and Cognitive Systems Laboratory of the University of Lübeck. I have German language skills up to B1 level and I am continuously improving my language skills. I am open to discussion in medical technologies and how medical devices can gain market access.
...See MoreWork Experience
Regulatory Affairs Specialist
Student Assistant At Robotics And Cognitive Systems Institute
Higher Education
Nilay Shah's Professional Milestones
- Regulatory Affairs Internship (2018-10-01~2019-02-01): Assisted in supporting compliance with regulatory requirements, gaining practical experience in the field of regulatory affairs.
- Student Assistant At Robotics And Cognitive Systems Institute (2019-08-01~2020-08-01): Provided invaluable support to academic and personal growth, promoting research and development in robotics and cognitive systems institute
Education
Regulatory Affairs For Medical Devices,
Biomedical/medical Engineering
1483228800-1577836800Skill
Regulatory Affairs
Python
Autocad
Unity
English
German
Working Abroad
Matlab
Certification
Colleagues
Robert Huber
professor - director and chair at universität zu lübeck
Inga Oberpichler
Managing Director | Center for Doctoral Studies
Christian W. Scheiner
full professor director of the institute for entrepreneurship & business development
Ulrich Günther
professor at universität zu lübeck director of the institue for chemistry and metabolomics
Dr Lisa Buddrus
postdoc & genetic engineering project manager at university of lübeck germany
Other Named Nilay Shah
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Nilay Shah works for Universität zu Lübeck
Nilay Shah's role in Universität zu Lübeck is Regulatory Affairs Specialist
Nilay Shah works in the industry of Higher Education
Nilay Shah's colleagues are Robert Huber,Inga Oberpichler,Christian W. Scheiner
Nilay Shah's latest job experience is Regulatory Affairs Specialist at Universität zu Lübeck
Nilay Shah's latest education in Universität zu Lübeck
