Miriam Klemke

Miriam Klemke has gained extensive work experience in regulatory affairs and project management in the medical device industry. Miriam began their career as a Guest Researcher at the Cancer Research UK Beatson Institute in 2015. From 2016 to 2017, they worked as a Regulatory Affairs Manager at SCC – Scientific Consulting Company GmbH, where they focused on international approvals and toxicological evaluations.

In 2017, Miriam joined Lohmann & Rauscher as a Regulatory Affairs Manager, responsible for developing and submitting technical documentation for medical devices. Miriam also managed strategic projects and engaged with authorities and notified bodies.

From 2020 to 2021, Miriam worked as a Regulatory Affairs Manager at Lindera, where they specialized in regulatory development and technical documentation for medical device software. Miriam also handled project management and communication with authorities and notified bodies.

In 2020, Miriam took on the role of Clinical Project Manager at NeuroNation, overseeing software as a medical device projects. Their responsibilities included regulatory compliance, risk management, clinical studies, usability engineering, and project management.

Currently, Miriam is employed as a Regulatory Affairs Manager at Vara. Their responsibilities include quality management, team leadership, managing medical device technical documentation, strategic project management, and serving as a regulatory specialist for artificial intelligence-based medical device software. Miriam also holds the role of Data Protection Officer.

Throughout their career, Miriam has demonstrated expertise in regulatory compliance, quality management, project management, communication with authorities and notified bodies, and the legal frameworks of the European Union and international standards.

Miriam Klemke's education history includes a Bachelor of Science (BS) degree in Medizinische Biologie from the University of Duisburg-Essen, which they obtained between 2009 and 2013. Miriam later pursued a Master of Science (M.Sc.) degree in Biomedizinische Wissenschaften, allgemein from the same university, completing it from 2013 to 2015. Additionally, they attended Kyoto University in 2014 for a short period to study Molecular Cellbiology, although no degree was specified.

In terms of certifications, Miriam Klemke has obtained several. In 2017, they received certifications in "Anforderungen an Design Dossiers für Klasse III Produkte" from TÜV SüD and "ISO 13485:2016 Medical devices" from Degens Quality Solutions. Miriam also holds a certification in "Google IT Security" from Google, obtained in November 2021. Furthermore, Miriam Klemke has certifications in "Datenschutzbeauftragter gemäß DSGVO & BDSG" (date of attainment not specified) from Bitkom and "Regulatory Affairs Management" (date of attainment not specified) from FORUM Institut für Management GmbH.