SH

Susan R. Hart

Director Regulatory & Quality Affairs at Hemex Health, Inc.

Susan R. Hart, PMP has over 25 years of work experience in various roles related to program and project management, regulatory and quality affairs, and new product development. Susan R. is currently the Director of Regulatory & Quality Affairs at Hemex Health, Inc., where they manage all aspects of quality and regulatory compliance for the company and its subsidiary, HemexDx. Prior to this, Susan provided consulting and contracting services through their own firm, Hart Consulting & Contracting LLC, primarily serving medical device development companies. Susan R. has also held positions at Dexcom, Welch Allyn, Inovise Medical, Agilent Technologies, and Hewlett-Packard, where they managed cross-functional teams and oversaw the development and release of new medical devices. Susan is experienced in working with regulatory agencies and has a strong background in program and project management.

Susan R. Hart, PMP has a strong educational background in computer science and business management. Susan R. holds an MBA from the Boston University - School of Management, specializing in an unspecified field of study. Additionally, they obtained an MS in Computer Science from California State University-Chico, with a focus on computer science. Susan also holds a BS in Computer Science from Montana State University-Bozeman, with a concentration in engineering. In terms of certifications, they have earned the Project Management Professional (PMP) certification from the Project Management Institute in November 2016. Although no information is provided about their other certification, they have obtained the AAMI Quality System Requirements and Industry Practice certification from an unspecified institution.

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Timeline

  • Director Regulatory & Quality Affairs

    November, 2020 - present