Mohamed Rasik Farith
Biomedical Engineer | Regulatory affairs Specialist | ISO 13485(QMS)| ISO 14971 | EU MDR & USFDA | Medical device documentation (TD, RMF, CER, SDLC, Submission) | Complaint handling.
- Role
- Lead Engineer at HCLTech
- Location
- Madurai, TN, IN
- LinkedIn followers
- 500 followers
About Mohamed Rasik Farith
Prepared and reviewed EU MDR 2017/745 Technical Documentation, including CER, RMF, GSPR, TD and Notified body commentsDeveloped and maintained Risk Management documentation in compliance with ISO 14971.Supported gap analysis, and regulatory assessments, FDA regulatory submissions, including 510(k) documentationPerformed PMS and PMCF activities, including data analysis, report preparation, and regulatory compliance tracking.Managed complaint handling processes in alignment with ISO 13485 and regulatory reporting requirements.Supported QMS documentation, including SOPs, design controls, and document control activities.Provided regulatory input throughout the SDLC, ensuring compliance during design, development, and post-market phases.Collaborated with cross-functional teams (R&D, QA, Clinical) to ensure timely regulatory deliverable
Experience
Lead Engineer
Feb 2025 — Present · Madurai, IN
Education
Sethu Institute of Technology
B.E , Biomedical engineering
2017 — 2021
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