Lalitha Balasubramanian

About Lalitha Balasubramanian

Motivated and high-energy clinical leader with 13+ years of proven experience in both start-up and large enterprises in clinical affairs, clinical operations, study execution, regulatory compliance and clinical strategy. Recognized for leadership on high impact cross-BU / cross-functional projects; consistent year-over-year high and exceptional performance; driven to continuously dive-in and add value. Demonstrated ability to work in new and high-pressure environments and thrives on challenges. Authentic leader, people advocate, quick learner, proactive problem solver and high energy team player.COMPETENCIES:Authentic leadership, employee engagement • Skilled in Relationship Building • Program and Project Management • Emerging markets • Effective Downward, Lateral and Upward Communication • Cross-functional team leadership • Influence Management • Emotional Intelligence • Dedicated & Adaptable Team Player • Lifelong Learner • Prioritization Skills • Extensive Medical Device Industry Knowledge • Clinical Trials • Trial Planning & Execution • FDA IDE studies • Cardiovascular device portfolio • Good Clinical & Documentation Practices (GCP/GDP) • Biomedical Engineering

Experience

1. Senior Clinical Evaluation Manager

   Medtronic

   Dec 2023 — Present

   Provide strategic leadership to a team of 8-10 Clinical Evaluation Specialists and Medical Writers involvedin maintaining EU MDR (European Medical Device Regulation) compliance. Overseeing regulatoryadherence of the Clinical EU MDR program, Global expansion submissions, staff development, processimprovements, and annual budgeting.

Education

• Louisiana Tech University

  Master of Science

• Northwestern University

  Human Anatomy

• Anna University

  Bachelor of Engineering (B.E.)