Jonathan Amaya-Hodges

Director, Technical Services

Jonathan has over 18 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery (injectable, ophthalmic, inhalation, central nervous system, etc.). Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD), in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan has and continues to be engaged with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics. 

Academic & Professional Qualifications:
  • B.S. Chemical Engineering, Northwestern University
  • ASQ Certified Manager of Quality/Organizational Excellence
  • ASQ Certified Quality Engineer
Training, Quality Systems, & Specialties:
  • Regulatory Affairs/Submissions/Strategy
  • Quality Engineering
  • Design & Development/Engineering
  • ISO 13485
  • ISO 14971
  • IEC 62366
  • ISO 11608
  • Engineering Statistics