Rita Lee, PhD, RAC

Principal Consultant

Rita has 15+ years of regulatory affairs strategy experience in regulated medical products (combination products, medical devices, and drugs) in startups and larger companies. As global regulatory device lead for devices and combination products over 5 years, she interacted with regulatory agencies, synergized/collaborated with product teams, and championed/proposed solutions-oriented, risk-mitigating regulatory strategy to market and post-market product modifications resulting in marketing approvals/clearances. Rita’s combination products experience has centered on drug delivery. She has guided medical device and combination product regulatory strategy for numerous products, including infusion pumps (pre-filled and user-filled), bioelectronics, mobile apps (software as a medical device, SaMD), in-vitro diagnostics (IVD), and inhalation devices (nebulizers, DPI).

Academic & Professional Qualifications:
  • B.A. English and Biology, Wellesley College
  • Ph.D. Biology, Syracuse University
  • Global and US RAC certifications
  • Professional Organizations: RAPS, DIA, NCRAF, WIB
Training, Quality Systems, & Specialties:
  • Regulatory Affairs/Strategy and Submissions
  • Combination Product Regulations
  • 510k
  • Gained CE Marks for devices per EU Medical Device Directive (MDD)
  • Regulatory & Scientific Writing