Rakesh Bombale
Engineer Medical Devices and Diagnostics| Complaint Handling | Medical Devices | Regulatory Affairs | Trackwise | SAP | ISO 13485 | US FDA | 21 CFR 820 | PMS COE
- Role
- Engineer at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Rakesh Bombale
6+ years of experience in Medical devices Complaints Management and Regulatory affairs.Sound knowledge in EU MDR- Complaint Remediation- Complaint Investigation- Creating eMDR- Root Cause Analysis (RCA)- Corrective action and preventive action (CAPA)- Quality Control- Complaint ClosureISO 13485 quality management system.ISO 14971 Risk Management.Complaints Handling for Siemens Healthineers- X-ray Products - MRI- CT product- Syngo - Advanced TherapyReviews and approves advertising and promotional materials to ensure consistency with approved claims and regulatory requirements.And worked for the biggest Medical devices Manufacturer Becton Dickinson client (BD).
Experience
Engineer
Jan 2022 — Present · Bengaluru, IN
Education
RNS Institute of Technology - India
Bachelor of Engineering - BE
2014 — 2017
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