Suganya Ranganathan
Specialist - QARA | EU MDR | US FDA | Health Canada | Indian Medical Device Rules | Quality Assurance and Regulatory affairs Engineer|NB coordination|Internal Auditor
- Role
- Regulatory Affairs Specialist at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Suganya Ranganathan
Internal Auditor · Health Canada · Document and Record control · QMS · EMI and EMC · Class IIb devices · Class Is devices · Technical Documentation · PSUR · PMS · Clinical Evaluation · 510(k) · Indian Medical device rules · EU MDR · PMDA · MDCG · U.S. Food and Drug Administration (FDA) · Technical Competence · Regulatory Requirements · Regulatory Filings · Medical Devices · Complaint Management · Design Control · ISO 13485. IMDR. Quality planning. Risk Mitigation. Risk Assessment and Control. Compatibility Testing. Verification and Validation. Lean Management, ETo Sterilization for Class Is, Class devices.
Experience
Regulatory Affairs Specialist
Jun 2025 — Present · Hyderabad, IN
Education
Sathyabama Institute of Science & Technology, Chennai
Bachelor of Engineering - BE, Electrical and Electronics Engineering
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