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Hi, I’m
ASHRAFUL MALLICK
Medical Device Complaint Investigator
KOLKATA
Work Preference
Summary
Detail-oriented Regulatory Compliance Specialist experienced in evaluating product complaints within Medical Device Reporting (MDR) framework. Enhanced processes and complaint handling through collaboration with regulatory teams and submission of comprehensive MDR reports. Knowledgeable in EU Medical Device regulations and FDA complaint regulations, ensuring compliance and safety within medical device environments.
Overview
3
Languages
1
Certification
4
years of professional experience
Work History
Wipro
Senior Associate
04.2022 - Current
Job overview
- Medical Device Complaint Handling (Post-Marketing Surveillance):
- Manage thorough processing of adverse event information while ensuring compliance with relevant FDA and global regulations alongside confidential operating procedures (SOPs) and guidelines.
- Manage and document incoming adverse event reports within one business day of receipt.
- Analyze all information from clinical and technical viewpoints to ensure meticulous analysis, investigation of root cause, and quality engineering review documentation preceding complaint closure.
- Investigated adverse events and product quality complaints while adhering to confidential operating procedures and utilizing product quality management system.
- ensure adequate information is collected to enable timely reporting, investigation, and resolution of reportable complaints including effective regulatory reporting decisions/justifications for worldwide reporting.
- Reviewed serious product complaints under internal confidentiality protocols, evaluated return samples for malfunction coding during assessments, and documented all pertinent complaint data to meet closure timelines.
- Collected adverse event data on marketed and developmental products, managed adverse event processes to ensure regulatory compliance, and coordinated with case receipt and medical review teams to optimize workflow.
- Complaint Management Specialist:
- Managed resolution of 500+ customer complaints within 30 days, achieving 23% improvement in overall customer satisfaction scores.
- Attained 95% customer satisfaction rate through effective complaint resolution as indicated in post-resolution surveys.
- Introduced new dashboard in complaint tracking system, decreasing resolution time by 40% and enhancing response efficiency
- Established and deployed complaint resolution framework leading to 60% decline in repeat complaints, improving overall customer experience.
- Led cross-functional teams to streamline project delivery timelines and enhance client satisfaction.
- Mentored junior associates, fostering professional growth and enhancing team performance through structured training sessions.
- Mentored junior associates, fostering professional growth and enhancing team performance through structured training sessions.
Education
Seacom Skills UniversityBolpur
Bachelor of Pharmacy from Pharmacy
04.2001
University Overview
GPA: CGPA 8.20
- Graduation with Distinction, [8th Semester, 2021]
National Board of Computer EducationBirbhum
Diploma in Computer Application
01-2018
University Overview
GPA: CGPA 9.05
Skills
Project management
Team leadership
Performance monitoring
Training and mentoring
Analytical reasoning
Dynamic adaptability
Task prioritization
Team conflict resolution
Communication proficiency
Certification
Diploma in Computer Application | National Board of Computer Education, Birbhum | 2017 - 2018 | CGPA 9.05
DECLARATION
DECLARATION
I hereby declare that the information provided is true and correct. I also understand that any willful dishonesty mayrender for refusal of this application or immediate termination of employment. Date: 2025-05-18 Place: KolkataAccomplishments
Accomplishments
- Achieved Top Investigator by completing 500 complaints with accuracy and efficiency.
- Supervised team of 5 staff members.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Availability
See my work availability
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Available
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Quote
If you really look closely, most overnight successes took a long time.
Software
Salesforce
MS Excel
MS Word
Power BI
Languages
English
Advanced (C1)
Bengali
Bilingual or Proficient (C2)
Hindi
Elementary (A2)
Interests
Reading Stories
Gardening
Creating Music Playlist
Timeline
Senior Associate
Wipro
04.2022 - Current
Seacom Skills University
Bachelor of Pharmacy from Pharmacy
04.2001
National Board of Computer Education
Diploma in Computer Application