Vigneshwaran Sundar
Sr. Regulatory Specialist at NeilMed Pharmaceuticals, Inc
- Role
- Senior Regulatory Affairs Specialist at NeilMed Pharmaceuticals
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Vigneshwaran Sundar
Mechanical engineer with 6+ years of experience in the Medical Domain with expertise in Product Development Life-cycle Management, FDA clearances/approvals, Regulatory due diligence, Change Control Management activities and Risk Management process. Possessing sound knowledge in Medical Device Regulations (US FDAs 21 CFR 820, EU\'s MDD & MDR, Health Canada, TGA) and Medical Standards (ISO 13485, ISO 14971, ISO 15223-1 and IEC 62366-1). Executed submission activities for medical devices across multiple regions including EUMDD & MDR, US (FDA), Health Canada, TGA, Malaysia, Saudi Arabia, Singapore, UAE, and New Zealand, ensuring compliance with local regulations and standards.
Experience
Senior Regulatory Affairs Specialist
Nov 2025 — Present · Bengaluru, IN
Education
Don Bosco Matriculation Higher Secondary School, Vellore
High School
Don Bosco Matriculation Higher Secondary School, Vellore
Higher Secondary , Mathematics and Computer Science
Adhiparasakthi college of engineering
Bachelor of Engineering - BE, Mechanical
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