Shobha Aggarwal manages Regulatory Strategy for Neuronoff.

Shobha has over 25 years of experience in product development, including 15 years of experience working in the medical device industry, leading teams in the development of Class II and Class III implantable medical devices. Over the course of her career, she has successfully managed product development from concept to commercialization for a wide variety of products including implantable systems, external systems and software.

Prior to Neuronoff, Shobha incorporated bionIQa, LLC, to provide consulting services in the areas of product development, operations, program management and preparation of regulatory submissions for commercial product approval.

Shobha also worked at Presidio Medical, Inc. overseeing the development of their novel Ultra Low Frequency neuromodulation system for the treatment of chronic pain. She managed the flagship program for the company, leading a cross-functional team of engineers, scientists, technicians and clinical researchers from the early stages of product development through design verification. She played an instrumental role in managing the operations and supply chain in order to ensure uninterrupted product availability. With extensive team leading experience as well as very broad technical knowledge in multiple fronts, including Hardware Engineering, Software Engineering, Mechanical Engineering, Compliance, Regulatory, Quality, and Manufacturing, she helped the team navigate through challenging requirements, and knock down roadblocks while staying focused on main targets and achieving success with the delivery of clinical trial product.

Shobha spent over five years working at SetPoint Medical where she worked with the product development, quality, regulatory and operations teams to design and build products that were used in feasibility as well as pivotal studies. From the definition of product requirements to selection and setup of suppliers to execution of design verification and creation of regulatory submission packages, she was instrumental in coalescing multiple streams of activity into an approved product for clinical trial and eventual commercial use. Prior to SetPoint Medical, Shobha worked at Advanced Bionics managing multiple implantable, external and software projects from concept through commercial distribution.

Shobha has developed expertise in markets and products used in the treatment of hearing loss, chronic autoimmune conditions as well as the treatment and management of chronic pain. In each of these roles, she has mastered the ability to wear multiple hats and identify potential issues across different departments and resolve them before they turn into showstoppers.

Shobha received her MS in Computer Engineering from UC Santa Barbara and her BE in Computer Technology from V J Technical Institute.