Kiran A. Chaudhari
Senior Executive
Pune
Summary
Highly accomplished and detail-oriented professional with approx 7 years of progressive experience in medical device complaint handling and investigation, Post-market surveillance and adverse event monitoring. Proven ability to meticulously investigate medical device issues, ensure compliance with regulatory standards (21 CFR part 820.198, 21 CFR part 803) and implement effective corrective and preventive actions (CAPA). Adept at collaborating with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to drive continuous improvement and maintain the highest levels of patient safety and device quality.
Overview
7
7
years of professional experience
3
3
Languages
Work History
Senior Executive
TATA Elxsi Ltd.
Pune
02.2022 - Current
- Responsible for Complaint analysis, Complaint investigation, Complaint reporting and evaluation, Complaint review and submission
- Evaluate medical and technical customer complaints.
- Ensured documentation compliance with 21CFR 820.198 standards.
- Creation, investigation and reporting of Medical Device Reports for submission to FDA if incident meets reportable criteria for both Malfunction and Serious Injury.
- Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 And 820
- Creation of PMS plans and reports.
- PMCF, PSUR, DSUR
- Worked on Risk Management file and devised documents such as Risk Management plans and reports, Hazard analysis, FMEAs as per ISO 14971.
- Creation of periodic quality review reports.
- Impact assessment & Health hazard assessment (HHE).
Junior Data Analyst
Cognizant Technology Solutions
Mumbai
02.2020 - 02.2022
- Knowledge of Quality System standards and regulations including 21 CFR 803 & 820 and ISO 13485 / 14971.
- Good understanding of FDA Medical devices classification, including the Premarket approval process or PMA and Premarket Notification or 510K.
- Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, close files appropriately within 60 to 90 days to meet metrics.
- Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
- Proficient in utilizing complaint management software Trackwise to log, track, and manage complaint investigations and resolutions.
- Using Queries and dashboard to manage complaint process flow
- Maintained meticulous records of all complaint investigations, corrective actions, and preventive actions (CAPA).
- Generated and distributed complaint reports to relevant departments, highlighting key trends and potential issues.
- Proficient in utilizing electronic quality management systems (eQMS) for complaint management workflows.
- Highlighting Investigation and Analysis Skills:
- Conducted thorough initial assessments of medical device complaints to determine severity and potential impact.
Pharmacovigilance Associate
TATA Consultancy Services
Mumbai
07.2018 - 02.2020
- Managed and processed adverse event (AE) and serious adverse event (SAE) reports from various sources (e.g., clinical trials, post-marketing surveillance, literature).
- Ensured accurate and timely data entry, assessment, and documentation of safety information in ARGUS and IRIS G databases.
- Conducted causality assessments and determined the expectedness of adverse events.
- Contributed to the preparation and review of aggregate safety reports (e.g., PSURs/PBRERs, DSURs).
- Participated in signal detection and management activities, including data mining and evaluation of potential safety signals.
- Supported risk management planning and the development of Risk Minimization Measures (RMMs).
Education
B. Pharmacy - undefined
H.S.C - undefined
S.S.C - undefined
Skills
Complaint handling
Complaint investigation
Trackwise
Post marketing surveillance
PSUR, DSUR
Aggregate reporting
Risk Management ISO 14971
Regulatory Affairs
Complaint files globally from Intake status to closure
Medical device reporting
Pharmacovigilance
Case processing
Reporting Activities
CAPA
ISO 13485
ISO 14971
21 CFR part 803
21 CFR part 820
Quality Management System
Personal Information
Date of Birth: 04/14/96
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
Senior Executive
TATA Elxsi Ltd.
02.2022 - Current
Junior Data Analyst
Cognizant Technology Solutions
02.2020 - 02.2022
Pharmacovigilance Associate
TATA Consultancy Services
07.2018 - 02.2020