Investigated 13,000+ Cases | Ensuring Compliance & Product Safety
I am a Biotechnology postgraduate with expertise in medical device complaint handling, regulatory compliance, and customer feedback investigation. Over the past two years, I have successfully investigated and resolved 13,000+ medical device complaint cases, ensuring adherence to MDR regulations and company SOPs.
Skilled in Trackwise, Salesforce, and regulatory documentation, I am passionate about quality assurance and product safety in the life sciences domain. My background in biotechnology provides me with a strong foundation in understanding medical devices and their applications, enabling me to conduct thorough investigations and contribute to continuous improvement in product quality.
Oct 2023 – Present
Investigating customer feedback management complaints using Trackwise & Salesforce, ensuring compliance with regulatory requirements and company standards.
Oct 2022 – Sep 2023
Handled Level 1 EMDR complaint investigations ensuring MDR compliance, proper documentation, and timely resolution of cases.
Apr 2022 – Oct 2023
Evaluated medical device complaints and ensured documentation accuracy, contributing to quality assurance and continuous improvement processes.
Investigated over 13,000+ cases across EMDR & CFM processes, maintaining a 98% compliance rate with regulatory requirements.
Medical Devices Quality Management System
Standard operating procedures and documentation standards
Complaint investigation and corrective action processes
Global regulatory requirements for medical devices
Drug safety monitoring and adverse event reporting
M.Sc. in Biotechnology (75%) - Vidyasagar University
B.Sc. in Biotechnology (62.33%) - University of Burdwan