Anbarasan Mohan
Medical Device Regulatory Professional | Labeling | EU MDR | US FDA | ISO 13485 | ISO 14971 | IEC 60601-X | IVD | Process Validation | Change Mangement
- Role
- Principal at Alcon
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Anbarasan Mohan
Master of Engineering with 9+ years of comprehensive experience in research and development, installation, application, service and maintenance, testing and calibration, and regulatory affairs in the medical device and in-vitro diagnostics (IVD) sectors. Knowledge in Equipment Validation, Process Design and Development, and Process Validation (IQ, OQ, and PQ).Extensive experience in change management, impact assessment, and change execution using ECR and ECN with Windchill OnePLM,Knowledge in creating quality and business deliverables to support the manufacturing design transfer and change process.Excellent interpersonal, analytical, and negotiating skills, as well as a track record of driving multiple cost-cutting projects over the course of a career.Having great knowledge and expertise with regulatory and quality requirements for medical devices and IVD products.Hands-on Experience with Medical Device Labeling, Gap Analysis, Complaint Handling, Regulatory Update, Data Integrity Assessment, Assay Library Update, and Country-Wide Regulatory Update.
Experience
Principal
Mar 2026 — Present · Bengaluru, IN
Education
Karpagam Academy of Higher Education
Bachelor of Engineering - BE, Electrical and Electronics Engineering
Anna University Chennai
Master of Engineering - MEng, Electrical and Electronics Engineering
2014 — 2016
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