Mazi Kiani

About Mazi Kiani

A mission-driven, results-oriented executive with a proven ability to navigate complexity and drive clarity in highly regulated, dynamic healthcare environments. Deep expertise in quality system development, global regulatory strategy, and FDA/international compliance, with a track record of delivering scalable solutions across both innovative startups and global multinational corporations. Recognized as a strategic and collaborative business partner, I am adept at leading transformational change, managing enterprise risk, and building high-performing teams while upholding appropriate standards of safety, compliance, and integrity.I have led quality and regulatory organizations for a broad array of medical devices, including class II & devices, biological/regenerative devices, combination devices, software as a medical device, and capital equipment. I am an active supporter of various non-profits within and outside of the United States.

Experience

1. Chief Quality & Regulatory Officer

   Heartflow

   Feb 2026 — Present

Education

• Cornell University

  Executive Leadership, Management

  2012 — 2013

• University of Washington

  Bachelor of Science - BS, Chemical Engineering, Chemistry

  1997 — 2002

Skills

• Fda Gmp
• Quality Management
• Risk Management
• Quality Assurance
• Pma
• Regulatory Affairs
• Quality Control
• Gmp
• Six Sigma
• Validation
• Iso 13485
• Usability Engineering
• Cmdcas
• Executive Leadership
• Design Control
• Functional Management
• Anvisa
• Iso 14971
• Design of Experiments
• Quality System
• V&V
• Medical Device Directive
• Design Dossiers & Technical Files
• Medical Devices
• Fda
• Capa
• Corrective and Preventive Action (Capa)
• Certified Lead Auditor
• U.s. Food and Drug Administration (Fda)
• Operational Excellence
• 21 Cfr
• Quality Engineering
• Mdr