Profile Details

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USD 80 /hr

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Hire Sneha V.

India

USD 80 /hr

Regulatory Affairs & Quality Assurance Professional | Medical Devices | Internal Auditor | Experienced in US FDA 510(k)

Profile Summary

A dedicated Regulatory Affairs and Quality Assurance professional (Medical Devices) having 3.4 years of experience in US FDA, EU MDD, and ISO 13485:2016 QMS, UDI, CER requirements, and submissions. Served as the Management Representative and primary regulatory point of contact in the global regulatory market. Completed and submitted a few design dossiers in the US and EU markets. A trained Internal Auditor for ISO 13485:2016 having participated and cleared many internal, external and market clearance audits. Involved and interacted with the product development team at all stages to maintain and improve product compliance and quality.

Subject Matter Expertise

• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Product Compliance
• ★ Medical Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Regulatory Consulting

Product Development Product Evaluation

Work Experience

Senior Associate - Quality Assurance and Regulatory Affairs

Niramai Health Analytix Pvt. Ltd.

January 2021 - Present

Quality Assurance and Regulatory Affairs Lead

ABM Respiratory Care LLC

September 2018 - July 2020

Biomedical Engineer

Elexes Medical Consulting LLC

February 2018 - September 2018

Education

MTech Biomedical Engineering

Amrita Vishwa Vidyapeetham

June 2015 - July 2017

BE Biomedical Instrumentation Engineering

Avinashilingam University

June 2011 - July 2015

Certifications

• European Medical Device Regulation

  TUV SUD

  August 2020 - August 2020

• Internal Auditing for Quality Management System for Medical Devices based on ISO 13485:2016

  TUV SUD

  August 2019 - August 2019