Kamini Gandhi
Regulatory Affairs Associate at MedMira Inc.- Claim this Profile
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English Professional working proficiency
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Hindi Professional working proficiency
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Gujarati Native or bilingual proficiency
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Bio
RAJENDR KUMAR GUPTA
Kamini was working in Invent Bio-Med Pvt Ltd Sachin Surat as a Quality Assurance & Regulatory Affairs. She was a hard working and fast problem solving person. She has a compact knowledge regarding Medical Devices and Pharmaceutical company. She was helping to resolve the Manufacturing process related issues also.
RAJENDR KUMAR GUPTA
Kamini was working in Invent Bio-Med Pvt Ltd Sachin Surat as a Quality Assurance & Regulatory Affairs. She was a hard working and fast problem solving person. She has a compact knowledge regarding Medical Devices and Pharmaceutical company. She was helping to resolve the Manufacturing process related issues also.
RAJENDR KUMAR GUPTA
Kamini was working in Invent Bio-Med Pvt Ltd Sachin Surat as a Quality Assurance & Regulatory Affairs. She was a hard working and fast problem solving person. She has a compact knowledge regarding Medical Devices and Pharmaceutical company. She was helping to resolve the Manufacturing process related issues also.
RAJENDR KUMAR GUPTA
Kamini was working in Invent Bio-Med Pvt Ltd Sachin Surat as a Quality Assurance & Regulatory Affairs. She was a hard working and fast problem solving person. She has a compact knowledge regarding Medical Devices and Pharmaceutical company. She was helping to resolve the Manufacturing process related issues also.
Credentials
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Regulatory Education for industry (REdl) - CDRH, CDER, CBER Track
FDA U.S. Food and Drug AdministrationJun, 2023- Nov, 2024 -
WHMIS
Nova Scotia Immigration and Population GrowthApr, 2023- Nov, 2024 -
Understanding How Medical Devices are Regulated in Canada
Health Canada | Santé CanadaMar, 2023- Nov, 2024 -
Auditing for Quality Management System for Medical Device based on ISO 13485:2016
TÜV SÜDJan, 2020- Nov, 2024 -
Arduino Software & Hardware
Gujarat Technological University, AhmadabadAug, 2015- Nov, 2024 -
CiC3 Robo Soccer
Gujarat Technological University, AhmadabadMar, 2015- Nov, 2024
Experience
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MedMira Inc.
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Canada
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Associate
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Apr 2023 - Present
• Quality Management System review • Assist with the maintenance of the quality system • Participates in Design and Development activities and ensures that all design projects and Design History Files comply with internal and external regulations. • The Risk Management procedure and maintenance of the Risk Management File Review • Assist with preparation and review of regulatory submissions, PMAs, 510(k)s, IDEs, CE Technical Files, Medical Device • Development of regulatory strategies for new or modified products Show less
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Nano Therapeutics
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India
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Assurance & Regulatory Affairs - Sr. Executive
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Dec 2021 - Sep 2022
R&D innovative Product Development/Product Manufacturing Process Development/CE Certification & ISO 13485 Quality Management System/Regulatory Guidelines & its requirements/Validation & Calibration process & documents/ Products Design & Development/All Production Department & Department Documentation/Internal & External Audit & Non conforms report prepared R&D innovative Product Development/Product Manufacturing Process Development/CE Certification & ISO 13485 Quality Management System/Regulatory Guidelines & its requirements/Validation & Calibration process & documents/ Products Design & Development/All Production Department & Department Documentation/Internal & External Audit & Non conforms report prepared
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Invent Bio Med Pvt. Ltd
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Surat, Gujarat, India
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Quality Assurance & Regulatory Affairs - Executive
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Jul 2016 - Dec 2021
Product Manufacturing Process Development/CE Certification & ISO 13485 Quality Management System/Regulatory Guidelines & its requirements/Validation & Calibration process & documents/ Products Design & Development Product Manufacturing Process Development/CE Certification & ISO 13485 Quality Management System/Regulatory Guidelines & its requirements/Validation & Calibration process & documents/ Products Design & Development
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Education
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2012 - 2016
Government Engineering College,Gandhinagar
Bachelor of Engineering - BE, Biomedical/Medical Engineering -
2008 - 2012
Sett R. J. J. High School, Valsad
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