Nikita Basandra

About Nikita Basandra

Strategically-minded Regulatory Affairs leader with a proven track record of securing high-stake approvals for Class II and medical devices. I specialize in bridging the gap between clinical innovation and global market access, with expertise in PMA/510(k) submissions, clinical trial strategy (IDE), and international compliance (MDR). My background combines a B.S. in Biomedical Engineering from Georgia Tech with a MBA from the Carlson School of Management, allowing me to provide regulatory guidance that is both technically sound and commercially transformative. I am a dedicated mentor and board member, committed to advancing the medical industry through both technical excellence and cross-functional leadership.Organizations & Leadership-President & Board Member | South Asian Arts & Theatre House (Non-Profit)-Affiliate Board Member | MILI, University of Minnesota-Mentor | Carlson Medical Industry Leadership Institute & Carlson Impact Lab-Mentor | Society of Women Engineers (SWE)Past Experience-Lead for Programming Pillar | Carlson Women Global Connect-Math Tutor | Catalyst OrganizationPast Internships: CR Bard, CIBA Vision, and Dental Clinical Support.

Experience

1. Director of Regulatory Affairs

   CVRx | Barostim

   Jun 2022 — Present

   Clinical Strategy: Secured FDA approval for the BENEFIT-HF Investigational Device Exemption (IDE), leading the regulatory negotiations necessary to initiate the clinical pathway-PMA & Labeling Expansion: Spearheaded the regulatory strategy for the FDA Phase 2 PMA approval of the BeAT-HF clinical trial, resulting in a significant labeling expansion for the Barostim System-Policy Leadership: Pioneered the company’s entry into the FDA’s Total Product Life Cycle Advisory Program (TAP) and shared insights as a featured panelist at the MD & M conference-Global Market Access: Direct strategic regulatory activities to ensure continuous MDR compliance and market availability-Executive Guidance: Serve as the primary regulatory representative in Management Review, providing senior leadership with critical updates on global filing strategies and project timelines-Organizational Excellence: Launched and mentored a high-performing Regulatory team. Pursued and implemented a better and more robust cross-functional review process for promotional and advertising materials.

Education

• Chattahoochee High School

  High School Diploma

• UMN Carlson School of Management

  Master of Business Administration (MBA), Medical Industry Leadership Institute and Entrepreunership Management

  2014 — 2017

• Georgia Institute of Technology

  B.S., Biomedical Engineering

  2006 — 2010