David Rigler Email & Phone Number

I have extensive experience in clinical and regulatory affairs executive management and hands-on in the development of innovative medical devices for rapid-growth biotech startups in Israel. My expertise lies in bringing conceptual medical device technologies to fruition in the fields of cardiology, ophthalmology, and metabolic syndromes for unmet clinical needs.My core competencies encompass a wide range of skills, including leading clinical research and development, regulatory affairs and quality assurance of active implantable class III medical devices with multi-disciplinary technologies, strategic business development, cross-functional team leadership, collaboration with strategic partners, establishment of SAB and KOL relations, pre-clinical research, surgical procedure and neuromodulation therapy program developments, technical writing and regulatory documents and scientific paper review, data analysis, grant applications, and mechanical design.I have successfully managed complex regulatory affairs processes in the US, Europe, and Israel, including IDEs, PMAs, HDEs, CE Mark, and AMAR.I hold an M.Sc.Eng. in Biomedical Engineering, a B.Sc.Eng. in Mechanical Engineering from the Technion, and a B.Sc. in Animal Science from the Hebrew University in Israel.

Listed skills include Medical Devices, Clinical, Clinical Trials, Gcp, and 46 others.