Madhumitha M
Global Labeling Specialist| EU MDR Compliance | Labeling Gap Assessment | R&D Collaboration | Verification Protocols and Reports| Process Optimization | Medical Disposables & Filters
- Role
- Senior Engineer-global Labeling Specialist at L&T Technology Services
- Location
- Coimbatore, TN, IN
- LinkedIn followers
- 500 followers
About Madhumitha M
As an enthusiastic Regulatory Labeling Analyst, I bring over 4+ years of experience in the medical device industry, specializing in labeling compliance, gap assessments, and documentation aligned with EU MDR 2017/745. My work has focused on ensuring end-to-end labeling alignment, from Labeling Requirement Specifications (LRS) to Redlining, Verification Protocols, and Labeling Reports.Currently serving as a Labeling Lead, I collaborate closely with cross-functional teams and stakeholders to deliver defect-free, first-time-right (FTR) outcomes. I have contributed to the successful regulatory readiness of a wide range of medical device products including:Product Families Supported: Disposables and FiltersTechnical CompetenciesRegulatory Standards: EU MDR 2017/745, ISO 13485 / CFR 820, ISO 15223-1, ISO 14971Quality Roles: Project Quality Analyst (PQA), Configuration Controller (CC SPOC), Defect Preventive Analyst (DPA)QMS & Tools: TrackWise, TeamCenter Unified, MS Office 365 (Word, Excel, PowerPoint)My VisionI am driven by the values of traceability, accountability, and consistency — ensuring labeling deliverables are not only compliant, but strategically aligned with patient safety, usability, and business timelines.
Experience
Senior Engineer-global Labeling Specialist
Jan 2026 — Present · Bengaluru, IN
Designated as the senior engineer supporting the Product life cycle management End to end labeling activities.
Education
Sri Ramakrishna Engineering College
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2017 — 2021
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