Basheerunnisa Mohammed Abdul

• Created and submitted electronic medical device reports for the

reportable complaints to the FDA through trackwise application as

per Medwatch form (Form 3500).

• Responsible for complaint intake, follow up, evaluation, investigation and submission of electronic medical device records to FDA.

• Deciding appropriate IMDRF codes and hazard ID by analyzing the complaint data, patient outcome, associated risk, hazardous

situation, root cause and failure modes of each complaint using SAP and Smax.

• Involved in the quality control and closure of complaints by reviewing and evaluating electronic MDR.

• Have sound knowledge of standards and regulations such as ISO

13485, ISO 14971, FDA 21 CFR Part 803,806 and 820.

• Accurately documented and categorized incoming complaints related to Flow cytometry and alaris pumps medical Devices, ensuring compliance with regulatory standards (FDA 21 CFR Part 820, ISO 13485).

• Collaborated with multidisciplinary teams, including engineers, quality assurance, regulatory affairs, and customer support, to investigate and resolve complaints effectively.

• Led in-depth investigations into complex complaints, applying root cause analysis (RCA) methodologies to identify underlying issues. Developed corrective and preventive actions (CAPAs) to address identified root cause.

• Ensured timely reporting of adverse events and serious complaints to regulatory authorities, adhering to FDA and international regulatory requirements. Zero regulatory compliance issues during tenure.

• Maintained clear and empathetic communication with customers and healthcare professionals throughout the complaint resolution process.

• Submitting regulatory records to the respective regulatory bodies(FDA, Health Canada).

• Achieved a 98% customer satisfaction rating for complaint handling.