Anushree Chavan
Angestellt, Regulatory Affairs Specialist, Tata Elxsi
India, Deutschland
Werdegang
Berufserfahrung von Anushree Chavan
Bis heute 8 Jahre und 10 Monate, seit Aug. 2015
Regulatory Affairs Specialist
Tata Elxsi
• Expertise in regulatory standard compliance • Hands on Experience on EU-MDR gap analysis, remediation & implementation • Proficiency in sterile medical device packaging compliance as per ISO 11607 and EU-MDR • Supported for EU-MDR notified body deficiency feedback response • Developed regulatory strategies for new and modified devices • Knowledge in change management, 510K submission, ISO13485, ISO11608, ISO14971, IEC60601, Post Market Surveillance, Clinical Evaluation Report & Risk management
Ausbildung von Anushree Chavan
3 Jahre, Juni 2012 - Mai 2015
Biomedical Engineering
University of Mumbai
Medical Imaging Modalities, Diagnostic Devices, Analytical Devices, and Biomaterials
3 Jahre und 1 Monat, Juni 2009 - Juni 2012
Biomedical Technology
MSBTE, Thane
Applied Mathematics, Biosensors, and Electronics