About
Highly accomplished Senior Associate specializing in Medical Device Complaint Handling and Post-Marketing Surveillance, with proven expertise in evaluating and investigating product complaints to ensure global regulatory compliance. Adept at preparing and submitting comprehensive MDR reports to regulatory agencies, leading process improvement initiatives, and implementing innovative solutions for compliant complaint management. Possessing in-depth knowledge of FDA regulations, ISO 13485, and EU Medical Device Regulations, I drive product safety and quality across the entire lifecycle.
Work
Wipro
|Medical Device Complaint Handling (Post-Marketing Surveillance) - Senior Associate
Kolkata, WB, India
→
Summary
Spearheaded medical device complaint handling and post-marketing surveillance, ensuring rigorous analysis, investigation, and regulatory compliance to maintain product safety and quality across global markets.
Highlights
Led comprehensive clinical and technical evaluations of product complaints, ensuring thorough analysis, root cause identification, and quality engineering review for timely closure.
Ensured stringent adherence to global regulatory standards including FDA (21 CFR), ISO 13485, CMDCAS, and PMDA, safeguarding product compliance and mitigating risks.
Streamlined information intake for reportable complaints, facilitating timely investigations and accurate regulatory reporting decisions for worldwide submissions.
Managed the end-to-end processing of adverse event information, ensuring full compliance with FDA and international regulatory guidelines and SOPs.
Efficiently triaged and tracked all incoming adverse event reports, achieving a 100% same-day processing rate for rapid response and regulatory compliance.
Executed comprehensive review and investigation of serious product complaints, including sample evaluation and malfunction coding, ensuring all data was meticulously documented for timely closure.
Confidential Company
|Complaint Management Specialist
Kolkata, WB, India
→
Summary
Managed and resolved customer complaints, implementing process improvements to enhance satisfaction and retention across diverse product lines.
Highlights
Resolved over 500 customer complaints within a 30-day period, boosting overall customer satisfaction scores by 23%.
Implemented a new complaint tracking dashboard, reducing resolution time by 40% and significantly improving customer retention.
Achieved a 95% customer satisfaction rate through effective complaint resolution, validated by post-resolution surveys.
Developed and executed a streamlined complaint resolution process, decreasing repeat complaints by 60% and enhancing overall customer experience.
Education
SEACOM SKILLS UNIVERSITY
→
B Pharmacy
Pharmacy
Grade: CGPA 8.20
Languages
English
Certificates
Diploma in Computer Application
Issued By
National Board of Computer Education
Skills
Regulatory Compliance
FDA (21 CFR), ISO 13485, CMDCAS, PMDA, EU Medical Device Regulations, MDR Reporting, Adverse Event Reporting.
Complaint Management
Product Complaint Investigation, Root Cause Analysis, Post-Marketing Surveillance, Complaint Tracking Systems, Customer Satisfaction, Process Improvement.
Quality Management
Quality System Policies, Confidential Operating Procedures (SOPs), Product Quality Management System, Data Collection & Analysis, Product Safety Data.
Software & Tools
Track wise, SAP, Salesforce, MS Word, MS Excel, MS PowerPoint, Basic Power BI.
Communication & Documentation
Technical Writing, Content Writing, Impactful Written Documents, Stakeholder Communication.
Professional Competencies
Critical Thinking, Conflict Resolution, Change Management, Time Management, Collaboration, Teamwork, Accountability, Problem-Solving.