Ady Banin

About Ady Banin

Regulatory Affairs Professional with over 18 years of experience in regulatory affairs and quality assurance within the medical device industry, specializing in Class II & medical devices. Proven track record in leading regulatory submissions across the US (510(k), IDE, PMA), EU (MDD, MDR), UK (EU MDR-based), and Israel (AMAR), managing risk assessments, quality systems, and cross-functional initiatives. Successfully led and passed FDA inspections and Notified Body audits with zero non-conformities. Expertise in developing regulatory strategies, streamlining submission processes, and collaborating across product development, operations, and quality functions. Recognized for driving compliance and successful product approvals in fast-paced environments.

Experience

1. Senior Regulatory Affairs Specialist

   Intuitive

   Jan 2025 — Present · Sunnyvale, CA, US

Education

• Technion - Israel Institute of Technology

  B.Sc., Biotechnology and Food Engineering

  2002 — 2006

Skills

• Quality Assurance
• Biotechnology
• Quality Auditing
• Internal Audit
• Chemistry
• Gmp
• Risk Management
• Cgmp
• Medical Devices
• Creative Problem Solving
• Capa
• Documentation
• Iso 13485
• Clinical Trials
• Microbiology
• Quality Improvement
• Clean Rooms
• Verification and Validation (V&V)
• Regulatory Requirements
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Quality System
• Quality Systems
• U.s. Food and Drug Administration (Fda)
• Sterilization
• Design Control
• Iso 14160
• Corrective and Preventive Action (Capa)
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• Quality Management
• Analytical Skills
• Clinical
• Class Iii Medical Devices
• Fmeca
• Medical Device R&D
• Process Validation
• Life Sciences