Ranjani Madhavan
Senior Regulatory Affairs Specialist @Sight Sciences
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WORK HISTORY
Senior Regulatory Affairs Specialist @Sight Sciences
EDUCATION
University of Madras
M.Sc, Food technology
ABOUT RANJANI MADHAVAN
Am a Medical device Quality and regulatory affairs professional with experience in establishing quality system based on ISO13485, Extensive experience in maintaining Quality Records, SOP, DHF, ECO/ECNs, performing CAPA and management review Meetings. Possess one-on-one interaction experience in dealing with ISO and CE auditors & Conducting supplier audits. My technical skills also include Knowledge of 510(k) & CE preparation, submission and clearance. Implementation of quality system regulation (21 CFR 820), Implementation of ISO14971 standards. Also, I have conducted several internal audits and am a certified Lead auditor for medical devices (ISO 13485 & ISO 9001). Am proficient in using MS office products (Excel, word, PowerPoint).
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