Jilu Cj
Lead Engineer – Medical Device Regulatory Affairs
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About
Lead Engineer – Medical Device Regulatory Affairs with 5+ years of experience supporting global regulatory compliance for medical devices. Skilled in FDA 21 CFR Part 820, ISO 13485, and ISO 14971 with strong experience in regulatory submissions, technical documentation, risk management, and product lifecycle compliance. Known for strong analytical thinking, regulatory strategy planning, and driving compliance in highly regulated environments.
Experience
Lead Engineer - Archimedis Digital - Chennai
(2025-06)
- Led and managed a team in Medical Regulatory Affairs, ensuring compliance with global regulatory requirements.
- Performed end-to-end Post Market Surveillance (PMS) activities for medical devices in compliance with FDA 21 CFR Part 820, ISO 13485:2016, and global vigilance requirements.
- Collaborated with cross-functional teams including Quality Engineering, R&D, Manufacturing, Medical Affairs, and Regulatory Affairs to perform Root Cause Analysis (RCA) for confirmed product trends.
- Performed risk assessments using Failure Mode & Effect Analysis (FMEA) investigation tool to support effective decision-making.
- Conducted technical scientific writing for complaint investigations, malfunction assessments, adverse event evaluations, and vigilance reporting.
- Ensured timely closure of complaint records while maintaining accuracy, data integrity, and regulatory compliance.
Product Regulatory Analyst - HCL Tech - Madurai
(2021-04 - 2025-03)
- Experience in handling complaints from start to end: Intake, Investigation, MDR, and Closure.
- Good knowledge of Medical Device Reporting (MDR) and US FDA requirements.
- Skilled in investigating complaints and identifying root causes and Worked on TrackWise for complaint handling, CAPA, and documentation.
- Managed regulatory documentation in strict compliance with ISO 13485 and ISO 14971 principles.
- Experience in reviewing customer communication and response letters.
- Experience in handling capital equipment complaints and US complaints.
- Knowledge of post-market surveillance (PMS) activities.
- Ensure timely and compliant resolution of complaints as per quality standards.
Product Regulatory Analyst - HCL Tech - Madurai
(2021-04 - 2025-03)
Project: Siemens Healthineers
- Experience in preparing PMSP, PMSR and PSUR Report as per regulatory requirements.
- Skilled in preparing Performance Evaluation Reports, including Analytical and Scientific Validity reports
- Experience in preparing Performance Evaluation Plan (PEP), Analytical, and Clinical Performance Reports (CER).
- Hands-on experience in Technical File preparation and GSPR checklist as per EU IVDR.
- Experience in preparing PMS audit reports.
- Worked on Smartsolve tool.
Education
Master of Engineering - Biomedical Engineering - Anna University (CEG Campus) (2019 - 2021)
Bachelor of Engineering - Biomedical Engineering - PSNA College of Engineering (2015 - 2019)
