Summary
Overview
Work History
Education
Skills
Websites
Certification
Accomplishments
Affiliations
Publications
Timeline
Generic

NIHARIKA MIRJI

Irvine,California

Summary

Proficient in current medical device regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Associate Specialist

APPLIED MEDICAL
03.2021 - Current
  • Actively managing regulatory activities for three product lines and subject matter expert in device labeling.
  • Preparing documentation for regulatory submissions for international markets such as UK and Europe.
  • Work with regulatory bodies and internal teams to obtain regulatory approval.
  • Successfully authored 510(k) for Class II device.
  • Collaborate with Engineering, Clinical Development and other departments in design and development process of our medical devices to ensure regulatory requirements are met in markets where devices are distributed.
  • Contribute to regulatory strategy planning and change management in US, EU, APAC, MENAT and other international markets.
  • Analyze impact of changes in different markets, propose multiple regulatory compliance pathways to cross functional team, plan implementation of projects.
  • Experience in interacting with regulatory bodies as part of on-site audit support and regulatory submissions.
  • Review and approve design controls and risk management file documentation.
  • Propose, initiate and drive business process improvement projects such as creating a tracker for 510(K) submissions that helps the author navigate through different stages of the process.
  • As labeling SME, provide regulatory input on all labeling projects, perform Gap and impact analysis on standards related to labeling such as ISO 15223-1;2021, ISO 20417;2021 etc.
  • Review and approve labeling content, product support material.

Research Engineer

EDITEKK, ENERGY DRIVEN TECHNOLOGIES, LLC
01.2020 - 12.2020
  • Chief research scientist leading in-vitro and in-vivo Biocompatibility test team in Toxicology studies, enzyme activity and Molecular biology assays evaluating the medical device (implantable spinal screw) per ISO 10993-1.
  • Leading the preparation for 510(K) submission by creating a template for submission along with writing supporting documents such as Standard Operating Procedures while setting up Product Lifecycle activities for the device.

Teaching Assistant

UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
01.2019 - 12.2020
  • Teach undergraduate juniors physiological signal acquisition, signal processing and data analysis
  • Conducted lab experiments, activities, tutoring, grading assignments, tests and reviewing work.

Research Affiliate

CANCER CENTRE, CARLE FOUNDATION HOSPITAL
10.2018 - 12.2019
  • Spearheaded the development of toxicology profile of PFAS compounds (found in teflon coating) to determine their role in different types of cancer using in-vitro experiments on Human HEPG2 cell line, HEK 293, LS 174T, MCF 7 cell lines.
  • Performed In-vitro experiments including Cytotoxicity testing using Fluorometric and colorimetric assays, epigenetic studies using DNA extraction, RNA extraction, Real-Time Polymerase Chain Reaction (RTPCR), flow cytometry to demonstrate epigenetic toxicity of these compounds.

Research Intern

DEFENCE BIOENGINEERING ELECTROMEDICAL LABORATORY, DRDO
12.2016 - 01.2017
  • Research Intern working on Powered Augmentative prosthetic leg project.
  • Collaborated with researchers and scientists to design and execute experiments.
  • Writing a comparison report on different technologies that are used to operate prosthetic legs that exist in market. Gathered and analyzed research data to create representative graphs and charts highlighting results for presentations.

Education

MASTER OF SCIENCE - Bioengineering with Cancer Nanotechnology concentration

University of Illinois At Urbana-Champaign
Urbana, IL
12.2020

BACHELOR OF TECHNOLOGY - Biomedical Engineering

Vellore Institute of Technology
Vellore, India
05.2018

Skills

  • Change Management
  • Regulatory Submissions
  • Audits
  • US FDA 510(k)
  • EU MDR technical file
  • UK CA technical file
  • Medical Device Labeling
  • Critical thinking
  • Communication and building relationships

Certification

Regulatory Affairs Certificate: Medical Devices, Regulatory Affairs Professionals Society (RAPS).

Accomplishments

  • 2nd runner up in Ingenium'17 by QuEST Global for the project on Powered prosthetic leg.
  • Merit Scholarship - 1st rank Biomedical engineering. (2016 & 2017)
  • Merit Scholarship - 2nd rank Biomedical engineering. (2014 & 2018)
  • Pratibha Puraskar - District level achievement award in the field of art.

Affiliations

  • Member, Engineering Graduate Student Advisory Committee, The University of Illinois at Urbana-Champaign.
  • Secretary, Bio Engineering Student Leadership Council
  • Community Service Head, IEEE-EMB, Vellore Institute of Technology
  • President, Interact Club of Ranebennur
  • Program Representative, Biomedical Engineering, Vellore Institute of Technology

Publications

  • Yi Wen, Niharika Niranjan Mirji, Joseph Irudayaraj: "Epigenetic Toxicity of PFOA and GenX in HepG2 Cells and Their Role in Lipid Metabolism", Toxicology In Vitro, 2020.
  • N. Mirji, S. Mishra and D. Maji: "PDMS micromachining for flexible 3D microdevice realization using Kapton tape as hard mask", 2019 IEEE Region 10 Conference (TENCON 2019), India, 2019.

Timeline

Regulatory Affairs Associate Specialist

APPLIED MEDICAL
03.2021 - Current

Research Engineer

EDITEKK, ENERGY DRIVEN TECHNOLOGIES, LLC
01.2020 - 12.2020

Teaching Assistant

UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
01.2019 - 12.2020

Research Affiliate

CANCER CENTRE, CARLE FOUNDATION HOSPITAL
10.2018 - 12.2019

Research Intern

DEFENCE BIOENGINEERING ELECTROMEDICAL LABORATORY, DRDO
12.2016 - 01.2017

MASTER OF SCIENCE - Bioengineering with Cancer Nanotechnology concentration

University of Illinois At Urbana-Champaign

BACHELOR OF TECHNOLOGY - Biomedical Engineering

Vellore Institute of Technology
NIHARIKA MIRJI