Neethi Murali
Senior Regulatory Affairs Specialist @Boston Scientific
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WORK HISTORY
Senior Regulatory Affairs Specialist @Boston Scientific
Mississauga, ON, CA
EDUCATION
Anna University Chennai
Bachelor of Technology - BTech, Chemical Engineering
University at Buffalo
Master of Science - MS, Chemical Engineering
Harrisburg University of Science and Technology
Master of Science - MS, Project Management
ABOUT NEETHI MURALI
PROFESSIONAL SUMMARY OF QUALIFICATIONS • 4 Years Quality/ Documentation / Regulations • Failure Modes & Effects Analysis • CAPA Management / Quality System • Documentation Control / Verification • Execution IQ/OQ/PQ activities • Process/Product Design / Improvements • Six Sigma / Lean Manufacturing • Equipment and Test Method Validation • Document Management Lifecycle • Electronic Document Management Systems • Design & Clinical Risk Management • Records Management • Engineering / Electronic Change Orders • Supplier Management / Compliance • Regulatory Compliance • Design of Experiments / Project Management • Internal and External (Supplier) Auditing • Technical Writing TECHNICAL SKILLS AND PROCESS KNOWLEDGE Software Systems: MS Office Suite / Minitab / Visio / MS Project / Windchill / ETQ / Adaptiv / Agile / CAPA Management / ERP/PLM Software / ETQ Reliance / MS Access / PTC Creo Parametric / Risk Management Plans / SharePoint / Summit / TrackWise Regulatory: GDP | cGMP | GMP | ISO 13485: 2016 | ISO 14971 | FDA | 21 CFR Parts 820, 210, 11 Process Experience: Process Validation (IQ/OQ/PQ) including cleaning, passivation, heat treating, and injection molding processes Technical Writing: Authored 100+ technical documents including SOPs, Device Master Record (DMR), Design History File (DHF), and Risk Management related documentation Change Control Systems: Monitored and controlled changes to approved manufacturing procedures, product design, SOPs, drawings, validation protocols, and surgical guides/labeling
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