ANJALI DHARMARAJ
REGULATORY ANALYST
Mahooz,Bahrain
Summary
Experienced Product Complaint Professional with over 2 years of expertise in product complaint investigation, adverse event analysis, and regulatory reporting. Consistent in evaluating safety data and determining reportability. Strong background in cross-functional collaboration with Quality, Regulatory, and Medical Affairs teams to ensure accurate and timely Medical Device Reporting (MDR), and support post-market surveillance activities.
Overview
2
2
years of professional experience
3
3
Certification
4
4
years of post-secondary education
Work History
PMS Analyst
HCL Technologies
Chennai
09.2023 - 12.2024
- Led comprehensive complaint handling for medical device products, ensuring adherence to global regulatory frameworks, including FDA 21 CFR 820/803 requirements.
- Oversaw high volumes of complaints using platforms such as TrackWise and Salesforce; applied IMDRF Annex coding, and leveraged clinical input and decision tree logic to assess reportability.
- Partnered cross-functionally with Quality Assurance, Medical Affairs, and Clinical teams to drive timely, thorough, and compliant resolutions.
- Authored and maintained Post-Market Surveillance (PMS) documentation in alignment with evolving regulatory guidelines and internal protocols.
- Improved operational efficiency by implementing automation and process enhancements, significantly reducing complaint turnaround time.
Regulatory Analyst
HCL Technologies
Chennai
10.2022 - 09.2023
- Worked on 10+ medical devices and checked if they adhere to national, international regulatory requirements, industry standards, and organizational policies.
- Prepared and reviewed regulatory documents, reports, and submissions for 5+ countries to ensure compliance with regulatory bodies' requirements.
- Identified potential compliance risks and issues and provided recommendations to mitigate regulatory risks in a timely manner.
- Monitored and analyzed changes in regulations for 5+ countries, 3+ ISO standards, and industry trends.
- Gained practical experience in preparing FDA 510(k) submissions in accordance with current regulatory requirements.
- Supported the update of performance evaluation reports (PERs), STED, general safety and performance requirements (GSPR) checklist, and declaration of conformity
Education
Bachelor's - Biomedical Engineering
Vel Tech Multi Tech Engineering College
Chennai 08.2018 - 06.2022
MBA - Healthcare And Hospital Management
SRM Institute of Science And Technology
Chennai 01.2025 - Current
Skills
- ISO 13485 - MQMS
- ISO 14971 - Risk management
- ISO 10993-1, IEC 62366
- 21 CFR 803 - MDR
- Regulations: US FDA, EU MDR
- Tools: MS Office, Trackwise, Sharepoint, JD Edwards
- Root cause analysis
- Complaint Investigation
Accomplishments
- Star Performer- Regulatory Center of Excellence.
- ERS Business Champion.
Certification
- Mini Course on EU MDR
- How medical devices are regulated in USA
- Post Market Surveillance of Medical Devices
Languages
Tamil
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Timeline
MBA - Healthcare And Hospital Management
SRM Institute of Science And Technology
01.2025 - Current
PMS Analyst
HCL Technologies
09.2023 - 12.2024
Regulatory Analyst
HCL Technologies
10.2022 - 09.2023
Bachelor's - Biomedical Engineering
Vel Tech Multi Tech Engineering College
08.2018 - 06.2022
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