Monisha Rashmi

Background

About Monisha Rashmi

A highly skilled and detail-oriented professional with 7+ years of experience in medical device complaint handling and post-market surveillance. Demonstrated expertise in managing and investigating complex customer complaints ensuring compliance with regulatory requirements such as FDA ISO 13485 and MDR. Proficient in root cause analysis risk assessment and CAPA implementation to enhance product safety and quality. Adept at cross-functional collaboration with quality regulatory engineering and manufacturing teams to drive continuous improvement and ensure timely resolution of issues. Strong analytical and communication skills with a proven track record of maintaining thorough documentation and reporting to meet both internal and external audit standards. Committed to upholding the highest standards of patient safety and product reliability in the medical device industry Expertise: Complaints handling Medical Device Reporting Post Market Surveillance Functions Life Sciences Trackwise Decision tree Complaint Investigation CAPA MedWatch ICSR and 21 CFR 803.