James Hart

Director of Medical Affairs for Abbott Automation Solutions

Lake Forest, Illinois, United States

About

Innovative medical scientist with 25 years of subject matter expertise in medical and analytical devices, including 15 years of industry experience developing and supporting highly complex in-vitro diagnostic systems.

Experience

  • Abbott (Full-time · 16 yrs 1 mo)
    • Director of Medical Affairs
      Jul 2025 - Present · 1 yr

    • Director of Medical Affairs
      Sep 2022 - Sep 2025 · 3 yrs 1 mo

    • Medical Director
      Jul 2019 - Sep 2022 · 3 yrs 3 mos

      • Ensure safety and compliance of Abbott Diagnostics clinical chemistry, immunoassay, automation, and informatics products in core laboratories across the globe • Author, review, and approve health hazard assessments, benefit-risk analyses, risk management reports, medical platform documents, etc., based on medical and technical subject matter expertise • Participate in senior management reviews of emerging issues, research and development milestones, and post-market surveillance metrics • Interface with numerous internal and external stakeholders, including regulatory agencies, key opinion leaders, third party manufacturers, auditors, and laboratory directors

  • MD/PhD Student at University of Rochester
    Aug 2001 - May 2010 · 8 yrs 10 mos