NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Roberta (Bobbi) Druyor-Sanchez

Practice Area Focus

  • Medical Devices
  • Regulatory Affairs
  • Project Management
  • ISO Certification
  • CE Mark Certification
  • Quality Management Systems
  • Risk Management

Biography

Bobbi Druyor-Sanchez, MS, is a Premier Expert consultant with NDA Partners. She is a bioengineer with expertise developing novel biotechnology products, successfully implementing ISO 13485, ISO 9001, and MDD/CE Mark Certification Quality Management Systems (QMS), initiating 510(k) clearance submissions, defining technical and product direction, implementing new customer reagents, developing microarray platforms and engineering systems. Some of Ms. Druyor-Sanchez's recent positions include Director of Quality and Regulatory at MedApps Inc./Alere Connect and VP of Quality and Regulatory at Exsomed. Before joining MedApps, she was Director of Systems Integration Engineering at Rose Street Labs/Kemeta LLC, and has held senior engineering positions at Motorola/Amersham/GE Healthcare, IMPRA (a subsidiary of C.R. Bard) and Ventana Medical Systems. For three years she was part of the mHealth (MRC) and CDS Coalitions, whose goal was to be a thought leader in mHealth and Clinical Decision Software ecosystems. Early in the FDA guidance development, these Coalitions worked with FDA, FCC, and IT Health to define policy such as the new MDDS and MMA guidances as well as the FDASIA report.