Kishore Vijaysujatha
Senior Manager, Global Regulatory Affairs @ Becton, Dickinson & Company (BD) | WWIPD | RAPS RAC Certified | ASQ Certified Medical Device Auditor (CMDA) | BSI Certified Lead Auditor (ISO 13485:2016)
- Role
- Senior Manager, Global Regulatory Affairs at BD
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Kishore Vijaysujatha
RAPS RAC‑Devices, ASQ CMDA, and ISO 13485:2016 Lead Auditor Certified Global regulatory affairs leader with 10+ years of experience driving regulatory strategy, NPD enablement, and global market access for complex medical devices. Currently Senior Manager, Global Regulatory Affairs at BD, leading regulatory strategy for next‑generation, software‑enabled infusion pumps and a comprehensive infusion set portfolio including pump, gravity, epidural, blood transfusion, and administration sets. Proven track record across FDA 510(k), EU MDR 2017/745, UK MDR, and Swiss frameworks, spanning Class devices, with strengths in regulatory governance, lifecycle management, and cross‑functional leadership.
Experience
Senior Manager, Global Regulatory Affairs
Jul 2025 — Present · San Diego, CA, US
Medical Devices Regulatory Submissions, Registrations & Compliance, New Product Development.World-Wide Infusion, Preparation & Delivery (WWIPD)Medication Management Systems (MMS)
Education
Arizona State University - Edson College of Nursing and Health Innovation
Master of Science - MS, Regulatory Sciences and Clinical Research
PES College of Engineering, Mandya
Bachelor of Engineering (B.E.), Mechanical Engineering
2011 — 2015
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