Swapna Chirala

About Swapna Chirala

15+ years of proven skills in medical device design, quality testing, R&D, clinical applications and technical support• Research with ultrasound systems and contrast agents to determine minimally invasive techniques for clot lysis • Stronghold on fundamentals of FDA regulatory affairs including 510(k) submissions, Risk Management Analysis and Product Development Life Cycle• Thorough understanding of MDD, AIMDD, CMDCAS, GMPs, ISO & FDA quality and regulatory requirements for medical devices • Self-motivated and hard working individual with excellent project management & presentation skillsSpecialties: FDA 510(k), ISO 13485:2003, MDD, AIMDD

Experience

1. Associate Director Regulatory Affairs

   Verathon

   Sep 2025 — Present · Bothell, WA, US

   Serve as a key strategic leader responsible for guiding and managing all regulatory aspects of Verathon’s products throughout their lifecycleEnsure compliance with all applicable regulatory, compliance, and clinical standards governing Verathon, Inc. products distributed globallyPrepare and obtain approval for product submissions to FDA and other worldwide regulatorsManage the planning, execution, and reporting of clinical evaluations of Verathon new products, as requiredLead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultantsManage the review and approval of product design, manufacturing and quality assurance changes, as well as marketing advertising and promotional materials to ensure compliance with internal procedures, applicable regulations and guidelinesProvide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon customers

Education

• Osmania University

  Bachelors, Biomedical Engineering

  2000 — 2004

• Drexel University

  Masters, Biomedical Engineering

  2004 — 2006

• Sandeepam Vidyalaya high school

  High School/Secondary Diplomas and Certificates

Skills

• Medical Devices
• Iso 13485
• Biomedical Engineering
• Fda
• R&D
• Quality System
• Medical Device Directive
• Quality Assurance
• Clinical Trials
• Testing
• Gmp
• Iso
• Ultrasound
• Technology Transfer
• Quality Management
• Quality Auditing
• Medical Imaging
• Healthcare
• Capa
• Validation
• Six Sigma
• Engineering
• Design Control
• Iso 9000
• Regulatory Affairs
• Regulatory Submissions
• Research and Development (R&D)
• Iso Standards