Alex Albert
PMS & Vigilance Reporting | Complaint Handling | Regulatory Compliance | TrackWise | ISO 13485 | US FDA | EU MDR
- Role
- Medical Writer at HCLTech
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Alex Albert
Experienced PMS & Vigilance Reporting Specialist for global medical device and…
Experience
Medical Writer
Sep 2022 — Present · Chennai, IN
Manage end-to-end complaint processing using TrackWise in compliance with ISO and CFR standards.Conduct regulatory reportability assessments and develop Global Decision Trees (GDTs).Submit MDRs, MIRs, and follow-up reports to USFDA, Health Canada, and EU Competent Authorities.Review medical records and assigned IMDRF codes for health impact assessment.Perform Device History Reviews (DHR), Root Cause Analyses, and implement CAPAs.Collaborate cross-functionally for label evaluations, FMEA, and risk mitigation strategies.Ensure documentation quality and compliance with internal SOPs and global regulatory standards.Draft Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) reports in compliance with EU MDR 2017/745.
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