Aditi Bhattacharya
Data Analyst at Wipro || FDA 21 CFR 820,803 || Class III Medical Devices || ISO 13485:2016 || FDA MDR & EU Vigilance || Post-Market Surveillance || Root Cause Analysis || Quality Compliance || Medical Device Reporting
- Role
- Data Analyst at Wipro
- Location
- Kolkata, IN
- LinkedIn followers
- 500 followers
About Aditi Bhattacharya
Data analyst with 3+ years of experience in Post-Market Surveillance (PMS), Materiovigilance, and Medical Device Complaint Handling. Skilled in Complaint Investigation Reports (CIR), root cause analysis, and maintaining global regulatory compliance for Class devices. Proficient in Salesforce for end-to-end complaint tracking and resolution across US, EU, LATAM, and EMEA markets.
Experience
Data Analyst
Dec 2021 — Present
Data analyst with 3+ years of experience in Class medical devices, supporting global markets including the US, EU, EMEA, LATAM, and BQ. Skilled in regulatory submissions, technical documentation, PMS, and complaint handling, with strong knowledge of FDA, EU MDR, and ISO standards. Proven ability to ensure compliance, support audits, and collaborate cross-functionally to drive regulatory efficiency and market readiness.
Education
Calcutta University, Kolkata
Master of Science - MS
2019 — 2021
Banasthali Vidyapith
Bachelor of Science
2016 — 2019
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