Nikita Basandra

Background

About Nikita Basandra

Work Experience: At CSI, I was responsible for the Coronary and Peripheral Atherectomy Systems (US), in addition to several new product development projects. I was awarded the Quarterly Recognition for exceptional performance and accomplishments at CSI, as supported by my mentorship roles, high-quality documentation practices, and critical Regulatory guidance. At Coloplast I supported the Female Health Surgical Urology Portfolio (WW), and the Men’s line as needed. This included assessing advertising and promotional materials, assessing changes related to the product/packaging, writing 510(k)s/PMAs, writing submissions to Canada/Europe (supporting submissions in other countries), and writing Summary Technical Documentation (STEDs). Prior to Coloplast, I worked for SJM as a Senior Regulatory Affairs Specialist and provided support for continuous improvement projects, new product development and registration for Cardiovascular products. Organizations: I currently serve as the following: 1. Carlson Women Global Connect Networking Lead for Programming Pillar 2. President and Board Member of South Asian Arts & Theatre House 3. Society of Women Engineers Mentor and Participant 4. Carlson Medical Industry Leadership Institute Mentor and Participant Internships/Volunteering: I have interned at CR Bard, CIBA Vision, and 2 dental offices. I have also volunteered at dental offices and several hospitals. I have tutored students from grades kindergarten to undergraduate university in math as part of the Catalyst Organization. I am also involved in a number of volunteering events in the community. Education: I graduated from the Georgia Institute of Technology with a B.S in Biomedical Engineering, which incorporated classes in Chemical, Material, Electrical, and Mechanical Engineering. I have also completed a MBA from the Carlson School of Business at the University of Minnesota, with a specialization in the Medical Industry Leadership Institute and in Entrepreneurship.