Prashant Rajput
Sr Regulatory Affairs Specialist at Aegis Lifesciences Pvt Ltd
Based in Bijnor, India
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Seniority
Staff
Department
Healthcare & Human Services
Location
Bijnor
Industry
Medical Equipment Manufacturing
Company size
110
Contact information
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p•••••••@aegis-lifesciences.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Prashant Rajput
I have 4 years of experience in the field of regulatory and clinical affairs as a medical writer. Great experience in writing and reviewing the clinical evaluation plan/report, PMCF plan/report, SSCP, PSUR, and Risk management. Good hand on experience in searching vigilance databases (MAUDE, TGA, Health Canada etc.). Greater experience in the preparation of technical files as per EUMDR 2017/745. Good knowledge of MDR 2017/745, MDCG guidance documents, MEDDEV 2.7/1 rev.4, GCP guideline, ISO 14971, ISO 14155.
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