Regulatory and Clinical Expert
PRO-LIANCE GLOBAL SOLUTIONS GmbH
I am Dr. Julia Rohrberg, a biochemist with a Ph.D., dedicated to medical devices and regulatory affairs.
Since January 2021, I've been a Regulatory Affairs Expert at PRO-LIANCE GLOBAL SOLUTIONS, where I've authored 30+ clinical evaluations, ensuring MDD and MDR compliance across diverse medical areas like orthopedics, wound care, and urology. I've also created biological assessments, PMS/PMCF plans, managed trials (ISO 14155), handled risk management (ISO 14971), and formulated product approval strategies. My grasp of European and US medical device regulations has enabled me to work seamlessly within clients' quality management systems, and I've contributed to the Medizinproduktejournal.
Previously, I pursued pioneering breast cancer therapies using kinase inhibitors during my postdoctoral stint at the University of California, San Francisco. My research on cell division and aggressive breast cancer garnered publications in top scientific journals and I served as a spokesperson in educational initiatives for breast cancer patients. During my years of research at the Technische Universität München I explored the biochemical and biophysical aspects of cancer protein folding.
My journey reflects dedication to advancing health. In my current role at PRO-LIANCE, overseeing various regulatory aspects of medical devices, I continue to shape healthcare significantly.
Disclosure information not submitted.
Wednesday, May 8, 2024
11:45 – 12:45 CEST