Elisa B.

+ Experienced Quality and Regulatory Affairs Manager with a strong background in the medtech industry, specializing in in vitro diagnostic devices (IVDs) and medical device software. I have been instrumental in guiding companies through complex regulatory landscapes, from developing Quality Management Systems (QMS) to achieving key certifications like EU IVDR and ISO 13485. + Fluent in English and a native Italian speaker, I have good command of German and bring over a decade of expertise in regulatory strategy, compliance, and quality assurance for both the EU and US markets. + My academic background, including a PhD in Molecular and Translational Biomedicine from the University of Zurich, where my dissertation and research focused on personalized medicine for oncology, and CAS in Clinical Research from the University of Basel, enhances my ability to deliver scientifically accurate, engaging content. I also have a passion for photography and am skilled in creating compelling visual and written content for various projects. I am dedicated to delivering high-quality results in remote projects, where I can leverage my skills to contribute to innovative projects in the healthcare, biotech, and medtech fields. In addition to my regulatory expertise, I offer freelance services in scientific writing, medical marketing, and translation.