Malavika Sivani S
Biomedical Engineer | Experienced in Medical Devices & Regulatory Operations | CMC Submissions & eCTD Compliance | Pfizer
- Role
- Lead Engineer (Medical Devices) at HCLTech
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Malavika Sivani S
Medical Electronics professional with expertise in regulatory affairs and medical…
Experience
Lead Engineer (Medical Devices)
Oct 2025 — Present · Chennai, IN
Support MDR remediation activities for high-risk interventional medical devices for Cook Medical (USA), focusing on DHF, Design Controls, and Risk Management.Execute DHF authoring and remediation activities for high-risk interventional medical devicesAlign Verification & Validation (V&V) documentation with MDR and Design Control requirementsIntegrate PFMEA/UFMEA with hazard analysis and complaint data (IMDRF coding)Perform product performance assessments, including complaint evaluation, nonconformance review, and risk impact analysisUpdate and maintain traceability matrices to ensure Design Input–Output–Verification–Validation linkageSupport manufacturing-related remediation strategies to strengthen regulatory compliance and risk-based decision-makingCollaborate with US regulatory and quality leads to ensure documentation integrity and MDR readiness
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