ECNE Senior Manager Projects / Operations

Dr. Nicole Darling is a clinical scientist, and biomaterials engineer whose experience spans medical device research, clinical evidence generation, regulatory documentation and project management. She combines a foundation in applied research with practical experience supporting medical technologies throughout their development and post-market lifecycle.

Working with ECNE Research, Nicole manages multidisciplinary projects involving clinical evaluation, systematic literature reviews, regulatory submissions and post-market evidence strategies. She collaborates with clients and specialist teams to assess safety and performance data, coordinate deliverables and translate scientific findings into clear clinical and regulatory documentation.

Previously, Nicole held clinical research and regulatory support roles at Terumo BCT, supporting a portfolio of more than 23 medical devices and solutions across EU MDR Classes I, IIa, IIb and III. Her work included post-market clinical follow-up, research using real-world data, clinical evaluation plans and reports, and summaries of safety and clinical performance.

Nicole holds a PhD in Chemical and Biomolecular Engineering from the University of California, Los Angeles, and completed postdoctoral research at the University of Colorado Anschutz Medical Campus. Her research explored biomaterials for tissue repair, stroke recovery and models of pulmonary fibrosis. She has co-authored peer-reviewed publications and completed JBI’s Comprehensive Systematic Review Training Program.

Her approach centers on connecting clinicians, researchers and industry teams to turn complex scientific evidence into practical support for product development and regulatory decision-making.