Ankit Dhaware
Sr. Executive Post marketing surveillance Analyst (Vigilance Reporting)||Regulatory and Quality Specialist well expertise in US FDA, EU MDR | Complaints Handling| RA & QA|21CFR803| Risk Management|
- Role
- Sr Executive Product Surveillance Analyst at Vantive
- Location
- Osmanabad, MH, IN
- LinkedIn followers
- 500 followers
About Ankit Dhaware
Currently working as PMS- Analyst Investigation @ BD in Global Compliant Handling (ASTA, SMAX, SAP_Depot and Intermountain) on TrackWise and SAP. Experience in complaint handling management 21 CFR 820.198, monitoring product/service quality through the complaint process, facilitating continuous improvement driven by the CAPA system, and generating complaint data, trending and analysis in TrackWise tool. Specialist in medical device (Class & Class II) new complaint intake, investigation of complaint and Performing MDR submission and the necessary supplemental records within timeliness to FDA as per the criteria defined by US 21 CFR Part 803. Familiarity with Medical Device Regulations such as FDA 21 CFR Part 820, Part 803, Part 806, EU regulations and ISO13485.
Experience
Sr Executive Product Surveillance Analyst
Feb 2025 — Present · Gurugram, IN
Education
ASPM's K.T. Patil College of Pharmacy Osmanabad-413501
Bachelor of Pharmacy
2017 — 2021
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Master in Pharmacy pharmaceutics
2021 — 2023
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor's degree
2017 — 2021
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor of Pharmacy - BPharm
2017 — 2020
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