Krishna Malve
Regulatory Affairs Manager @Arkray Healthcare Pvt. Ltd
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WORK HISTORY
Regulatory Affairs Manager @Arkray Healthcare Pvt. Ltd
Surat, IN
Technical Documentation preparation, Review and submit for EU IVDR 2017/ 746.* Review of IFU, Label as per Indian Regulations and EU.* Country Specific Registration for Medical Device and IVD.* Import and Manufacturing registration/License for medical devices/IVD.* State Pollution Control Board Compliance for Plant as per Medical Device and IVD * Environmental Compliance, Import Compliance, BIS compliance, for Medical Device and IVD.
EDUCATION
School of pharmacy
Bachelor's degree
Swami Ramanand Teerth Marathwada University
M Pharmacy
ABOUT KRISHNA MALVE
Regulatory affair experience in CDSCO, Medical device, Biologicals, CDT, Technical files…
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