Megan Lamberti

About Megan Lamberti

Over 10 years of experience in clinical and regulatory affairs for the development and introduction of novel medical devices, in vitro diagnostics and pharmaceutical products. Master of Translational Medicine degree from the Bioengineering departments of University of California, San Francisco (UCSF) and UC Berkeley and a BS in Biomedical Engineering from Johns Hopkins University. Began career working on low-cost medical devices for resource scarce healthcare environments. Then worked as an engineer for start-up medical device companies and transitioned to managing clinical and regulatory affairs for a start-up developing diagnostic equipment for the ICU. Since 2018, has worked as a consultant specializing in clinical trial design and execution and regulatory affairs, including medical writing services. Have worked as a clinical research associate (CRA), monitor and project director on the CRO side of research, in industry, managing clinical affairs on behalf of clients, and in academia as a clinical research coordinator, which has yielded cross-functional skillsets in the conduct of clinical research. Certified Clinical Research Associate (CRA) and expertise with a wide variety of medical devices and in vitro diagnostic products across medical specialties. Held roles in medical and technical writing, project management, manufacturing oversight, regulatory submission compilation, development of EDC systems, clinical trial design/initiation/execution/closure, data management, regulatory strategy, non-clinical lab work, and clinical fieldwork. Expertise in institutional review board (IRB), 510(k), PMA, orphan drug designation (ODD), investigational new drug (IND), CMS coverage request, investigational device exemption (IDE), breakthrough device, and technical file regulatory submissions and has worked on numerous non-significant risk (NSR), IDE and IND trials.Worked in specialties including but not limited to critical care, stroke, transplant, STEMI, sleep apnea, obstructive airway diseases, subarachnoid hemorrhage, cerebral vasospasm, continuous insulin infusion, glucose monitoring (CGM), intracranial aneurysm, obesity, plasma adsorption, traumatic brain injury, subdural hematoma, congenital disorders, COVID-19 and hyperinflammatory conditions, hyperbaric oxygen therapy (HBOT), CAUTI, total artificial heart, peripheral nerve repair, retinal imaging, retinal drug delivery, saliva, blood, and plasma-based diagnostics, incisional hernia, local delivery drug-loaded nanoparticles, uterine contractions, and birth asphyxia.

Experience

1. Vice President of Clinical and Regulatory Affairs

   Nilo Medical Consulting Group

   Jun 2024 — Present

Education

• University of California, Berkeley

  Master's Degree, Biomedical Engineering

  2014 — 2015

• University of California, San Francisco

  Master's Degree, Biomedical Engineering

  2014 — 2015

• The Johns Hopkins University

  Bachelor of Science - BS, Biomedical Engineering

  2010 — 2014

Skills

• Data Analysis
• Glucose Meters
• Global Health
• Regulatory Affairs
• Lifesciences
• Biomedical Engineering
• Research
• Maternal-Child Health
• Cancer
• Continuous Glucose Monitoring
• Molecular Biology
• Patents
• Fda
• Cell Culture
• Biocompatibility
• Fmea
• Manufacturing Engineering
• Biotechnology
• Medical Devices
• Clinical Research