Sabarivel R

Regulatory Affairs Executive @Morulaa Healthtech Pvt. Ltd

Chennai, IN

Managed end-to-end regulatory submissions via CDSCO (MD Sugam); prepared and submitted Final client dossiers• Ensured compliance with IMDR, ISO 13485, and ISO 14971; maintained up-to-date regulatory knowledge.• Facilitated import license approvals; coordinated with authorities and internal stakeholders.• Handled query responses and submission tracking on the CDSCO portal.• Supported internal and external audits; ensured readiness and compliance alignment.• Collaborated with R&D, QA, and Legal to integrate regulatory needs across the product lifecycle.• Conducted regulatory risk assessments and gap analysis for new products.

Sethu Institute of Technology

Bachelor of Engineering - BE, Biomedical/Medical Engineering

Velammal Metric Higher Secondary School - Viraganoor

Higher Secondary School Certification, Bio Maths

Sathyabama University

Master of Technology - MTech, Medical Instrumentation