Sushma Rao

About Sushma Rao

Senior Regulatory Affairs professional with extensive experience in US and International Regulatory Affairs in class II and Medical devices including Devices containing software, IVD and AIMD. Hands-on Global Regulatory strategy planning, development and execution. Regulatory Program Management. Monitoring, analyzing, interpreting and integrating emerging Regulations.~510K, PMA, De Novo classification, Q-subs, FDA Breakthrough Device Designation ~Global Registrations: APAC, LATAM, META, ASEAN and other Regulated Markets ~Labeling, Ad and Promo, Digital Marketing Compliance ~Technologies experience: Cardiology (Cardiac electrophysiology w/3D mapping & recording (HW/SW), Intracardiac Ultrasound, Cardiac Catheters) Neurology (SCS and DBS Systems and accessories), IVD (CC and MB Assays and Analyzers), Digital Health ~SAMD, SIMD, AI/ML, Cybersecurity

Experience

1. Senior Manager, Regulatory Affairs

   飞利浦

   Jul 2022 — Present · Bothell, WA, US

   Automated external defibrillators and accessories

Education

• National College Of Pharmacy, Kuvempu University

  BS in Pharmaceutical Sciences

• The Johns Hopkins University

  Master's degree, Regulatory Science

  2015

• Massachusetts College of Pharmacy and Health Sciences

  MS, Industrial Pharmacy

• Regulatory Affairs Certified

  RAC (US)

Skills

• Pma
• Biotechnology
• Software Regulations
• Validation
• Quality System
• V&V
• Regulatory Affairs
• Clinical Trials
• 510k
• Gmp
• Regulatory Requirements
• Ivd
• Design Control
• Biologics
• Pharmaceutical Industry
• Fda
• Ide
• Medical Devices
• Regulatory Submissions
• 21 Cfr Part 11
• Apac Submissions
• Verification and Validation (V&V)
• U.s. Title 21 Cfr Part 11 Regulation
• Green Initiatives
• U.s. Food and Drug Administration (Fda)
• R&Tte
• Iso 13485