Vaishnavi Borade

Experience

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  Holden Medical Laboratories

  Dec 2020 - Jan 2021

  Internship Program

  Experienced in applying GMP, GCLP, and CLIA regulations to optimize compliance and operational processes• Developed standardized protocol template system, enhancing consistency across nonclinical protocols and improving regulatorycompliance• Implemented comprehensive document lifecycle management workflow, optimizing tracking and control for critical regulatorysubmissions• Assisted in a quality improvement initiative as a Medical Lab Quality Intern, applying Good Clinical Laboratory Practice (GCLP) andClinical Laboratory Improvement Amendments (CLIA) regulations to optimize compliance and operational processesand batch records, contributing to GMP compliance.Assisted in internal audits and participated in the implementation of Corrective and Preventive Actions (CAPA)based on audit findings, ensuring compliance with regulatory standards. Show less

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  Meril

  Feb 2022 - Nov 2022

  Consultant- Clinical Regulatory Writer

  Clinical Study Report Writing: Authored and managed comprehensive Clinical Study Reports (CSR), ensuring accurate representation of clinical data and alignment with regulatory requirements.Ethics Committee (EC) Submission: Prepared and submitted essential study documents for Ethics Committee (EC) approval, ensuring compliance with ethical guidelines and regulatory frameworks.PMCF Plan and Report Preparation: Developed and finalized Post-Market Clinical Follow-Up (PMCF) plans and reports, contributing to ongoing product safety and performance evaluations in accordance with EU MDR.Supported quality documentation for product development, including risk management files and design control documents.Data Verification: Conducted rigorous data verification processes to ensure the accuracy and integrity of clinical and regulatory documents prior to submission.Study Documents Verification: Verified the completeness and correctness of study documents, ensuring they meet both regulatory and study-specific requirements. Show less

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  Tata Elxsi

  Nov 2022 - Aug 2023

  Engineer- Medical Electronics

  Authoring Regulatory Documents: Prepared and finalized key regulatory documents such as Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), and Post-Market Clinical Follow-Up (PMCF) reports, ensuring compliance with EU MDR, FDA, and other global regulatory standards.Literature Search and Data Extraction: Extensive experience in conducting literature reviews and extracting relevant clinical data using databases like PubMed, Cochrane, and EMBASE to support regulatory submissions and clinical evaluations.Managed and maintained design quality documentation, including DHFs and DMRs, for Class II and III devices.Experience with Various Medical Devices: Worked on a diverse range of medical devices, including cardiovascular and orthopedic devices, contributing to the development of regulatory strategies, risk assessments, and documentation for product approvals. Show less