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

Roberta (Bobbi) Druyor-Sanchez, MS

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 Partner with NDA Partners and has worked with the company as an Expert Consultant since 2014. She is a bioengineer with expertise in developing novel biotechnology products, defining technical and product direction with a focus in start-up company environments, implementing FDA’s QSR, ISO 13485, and MDD/CE Mark Certification Quality Management Systems (QMS), 510(k) clearance submissions, and engineering/ software systems.

Ms. Druyor-Sanchez was formerly Director of Quality and Regulatory at MedApps Inc./Alere Connect, and Vice President 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. 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.