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Yashmin Khatun

@yashminkhatun

Message

Detail-oriented healthcare professional specializing in medical device compliance.

India

Message

What I'm looking for

I am seeking a challenging role that allows me to leverage my analytical skills and commitment to patient safety while contributing to quality-driven initiatives and regulatory adherence.

I am a detail-oriented and quality-focused healthcare professional with 2 years of experience in medical device reporting. My expertise lies in post-market surveillance, medical device complaint handling, and regulatory reporting. I am skilled in ensuring compliance with international regulatory requirements, including EU MIR, MHRA, and Health Canada, while maintaining high standards of patient safety.

In my current role as a Senior Associate at Wipro, I have logged, validated, and triaged medical device complaints, ensuring timely and accurate case entry. I collaborate with cross-functional teams to retrieve missing data and documentation, and I contribute to trend analysis and complaint reviews. My commitment to continuous improvement and regulatory excellence drives my work in the medical device industry.

Experience

Work history, roles, and key accomplishments

Current

Senior Associate

Current

Wipro

Jun 2023 - Present (2 years 1 month)

Logged, validated, and triaged medical device complaints based on severity and reportability, ensuring timely and accurate case entry. Performed reportability assessments of complaints to determine if they qualify as Serious Incidents, evaluating causality, severity, and expectedness.

Regulatory Reporting Root Cause Analysis Documentation EU MIR Complaint Handling Data Entry

Global Complaint Management Analyst

Wipro

Jul 2023 - Present (2 years)

Coordinated with cross-functional teams to retrieve missing data and documentation, communicating with stakeholders for receipt confirmations and case updates. Maintained organized, compliant case files aligned with regulatory timelines and contributed to trend analysis and complaint reviews.

Cross Functional Collaboration Regulatory Compliance Data Management Case Management Systems Trend Analysis Documentation Regulatory Reporting

Education

Degrees, certifications, and relevant coursework

JIS University

Bachelor of Pharmacy, Pharmacy

Completed a Bachelor of Pharmacy degree, gaining foundational knowledge in pharmaceutical sciences. Studied various aspects of drug development, pharmacology, and patient care.