Lisa English serves as the Principal Clinical Scientist at EBR Systems, Inc., where she plays a pivotal role in advancing the company’s innovative medical device solutions. With a robust background in neuroscience, complemented by her PhD from the University of Minnesota Medical School, Lisa brings...
Lisa English serves as the Principal Clinical Scientist at EBR Systems, Inc., where she plays a pivotal role in advancing the company’s innovative medical device solutions. With a robust background in neuroscience, complemented by her PhD from the University of Minnesota Medical School, Lisa brings a strategic and analytical approach to her work. Her expertise encompasses a wide range of responsibilities, including the development of Clinical Evaluation Plans and Reports, as well as ensuring compliance with regulatory standards such as the Medical Device Regulation (MDR) and ICH guidelines.
At EBR Systems, Lisa is instrumental in crafting comprehensive clinical documentation to support FDA Premarket Approval (PMA) submissions. Her role involves not only the creation of clinical study protocols and reports but also the execution of post-market clinical follow-up and periodic safety update reports. By leveraging her skills in regulatory affairs and medical writing, she ensures that the clinical data aligns with market access strategies and regulatory requirements, thereby facilitating a smoother pathway for product approval.
In addition to her writing responsibilities, Lisa is adept at conducting thorough literature searches and reviews, ensuring that all clinical evaluations are grounded in the latest scientific evidence. Her collaborative approach fosters teamwork across various departments, enhancing the overall efficiency of clinical research initiatives. With certifications in Medical Publications and Regulatory Affairs, Lisa is well-equipped to navigate the complexities of the pharmaceutical industry, particularly in the context of diabetes-related medical devices. Her commitment to regulatory compliance and her strategic insights make her a valuable asset to EBR Systems and the broader medical device community.
