Pravin Siva P
Post Market Surveillance Analyst at HCLTech | Complaint handling | Trackwise | Medical device compliance | IMDRF code mapping | FMEA | EU MDR | Risk Management | Technical Documentation | Agile PLM
- Role
- Data Analyst at HCLTech
- Location
- Madurai, TN, IN
- LinkedIn followers
- 500 followers
About Pravin Siva P
Post Market Surveillance Analyst with 3+ years of experience in medical device complaint handling, risk management, DFMEA/AFMEA validations, and PMS activities. Skilled in Track Wise, Agile PLM, documentation control, and regulatory compliance (EU MDR, IMDRF codes). Proven expertise in conducting investigations, preparing technical documentation, and supporting design assurance for MedTech products.
Experience
Data Analyst
Apr 2025 — Present · Madurai, IN
Becton Dickinson Experience in handling customer complaints for BD products that came from the EMEA region such as Intake, Decision tree (vigilance report ability check), sending Acknowledgement Letters and Closure Letters to the customer, post investigational follow-ups of the complaint records and mail management of customer complaints for all the BD Business Unit.Utilized TrackWise to manage quality records, CAPAs, and document control processes.Based on various regions the complaints also came in native languages that can be handled using translator tool \"DeepL\" for all the process and communication.Focus on post-market surveillance and managing medical device complaints. Demonstrated expertise in the complaint intake, MDR and MIR submission processes, investigation, quality control and ultimate closure for medical devices. Completed essential end-to-end business procedures, such as the following:Complaint history review, Design history review, risk evaluation, Return sample review results, Investigation summary, reportability determination and the IMDRF Annex A, B, C, D, E, F, and G codes.
Education
SNS College of Technology
Bachelor of Engineering - BE, Mechanical Engineering
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