Balagangadharan A
Quality & Regulatory: Complaint Investigator & Vigilance Reporting Specialist | Medical Devices | Regulatory Affairs | Lean Six Sigma Green Belt Certified | QA | Post Market Surveillance - Complaints Handling |
- Role
- Quality & Regulatory Complaint Investigator & Vigilance Reporting Specialist at Philips
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Balagangadharan A
Experienced Mechanical Engineer with a demonstrated history of working with Medical…
Experience
Quality & Regulatory Complaint Investigator & Vigilance Reporting Specialist
Jan 2024 — Present · Pune, IN
Responsible for Vigilance Reporting as a dedicated resource including reporting decision making (GDT), writing and submitting MDRs/MIRs, and preparing responses to competent authority inquiries.Handles Vigilance Reporting responsibilities, including collaborating with complaint investigators to drive investigation to conclusion.Developing professional expertise, applies company policies and procedures to resolve a variety of issues.Frequently interacts with subordinate supervisors and functional peer groups.Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.Works on issues where analysis of situation or data requires review of relevant factors.Exercises judgment within defined procedures and policies to determine appropriate action.Serves as individual contributor, working to meet schedules and resolve problems.Works with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.Utilizes global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements.Collaborates with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review.Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion.Writes MDRs/MIR reports and submits to the necessary authorities.Monitors and improves tracking/control systems for medical device reporting.
Education
KCG College Of Technology
Bachelor of Engineering (B.E.)
2010 — 2014
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