Amith Padmanabhan
Senior Regulatory Engineer at Ilensys Technologies Pvt Ltd
Based in Hyderabad, India
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Seniority
Staff
Department
Engineering
Location
Hyderabad
Industry
Engineering Services
Company size
518
Contact information
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a•••••••@ilensys.com
Phone
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Background
About Amith Padmanabhan
Strategic and globally experienced Regulatory Affairs Professional with nearly 10 years of success in navigating complex global regulatory landscapes across the medical device, life sciences, and electronics industries. Proven leadership in international product approvals, EU MDR/IVDR transitions, and cross-functional compliance strategy. Adept at managing regulatory frameworks across the EU, US, and APAC regions while collaborating with stakeholders, notified bodies, and regulatory agencies. Seeking a leadership opportunity as a Global Regulatory Affairs Manager to drive global compliance, accelerate market access, and shape regulatory strategy at scale.CORE COMPETENCIES• Global Regulatory Strategy (EU MDR, IVDR, FDA, RoHS, REACH)• Regulatory Project Management (New Market Access & Maintenance)• Technical Documentation | CE Marking | Risk Management (ISO 14971)• ISO Standards (ISO 13485, 9001, 17025)| GSPR | UDI Systems• Regulatory Submissions | Product Lifecycle Management• Internal & External Audit Support | Regulatory Inspections• Cross-functional Collaboration | Regulatory Intelligence• Stakeholder Management | Team Mentoring & Training
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