HARSHITHA JN
Bengaluru
Summary
I am an optimistic individual determined to achieve my goals and dreams. My dedication to my work drives me to provide unique solutions to the various problems I encounter. Through my educational journey and work experiences, I have developed a strong foundation in Medical Electronics and possess skills in health care industry.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Regulatory Affairs Engineer
Prognosys Medical Systems Pvt Ltd
Bangalore
06.2024 - Current
Focusing on Regulatory Affairs Activities
- Write, analyze, and edit technical documents, Design Files to support country- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including submissions in India, USA, Europe and other Countries.
- Maintenance of QMS / ISO 13485 documentations - Preparing and maintaining Quality Manuals and Procedures
- Maintain regulatory files. Maintain and update regulatory authorizations, such as CDSCO submissions , 510(k)s, and CE dossiers for EU.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of noncompliance.
- Perform Clinical evaluation activities during new product development and regular updation of the files
- Monitor and control the implementation of regulatory compliance in the organization.
- Development and maintenance of risk management files in accordance with relevant standards (e.g., ISO 14971).
QA-RA Intern
Prognosys Medical System Private Limited
Bangalore
02.2024 - 06.2024
QA-RA Internship focused on quality assurance, Quality Management and Regulatory Affairs.
- Basics of ISO 13485 and Documentation
- Training on Radiology Equipment like C-Arm, Fluoroscopy, Mobile and Fixed X-Ray Machines
- Basics of CDSCO, AERB, EUMDR, US FDA
- Working on Clinical Evaluation Report
Intern
SpOvum Technologies Private Limited
Bangalore
08.2023 - 09.2023
Internship focused on embryo selection processes and machine learning.
- Automation of Embryo Selection Process
- Basics of ML(CNN)
- Annotations and Anaconda Software
Education
B.E. - Medical Electronics Engineering
Dayananda Sagar College of Engineering
Bengaluru05-2024
12th Grade -
National PU College
Hospet, Vijayanagara04-2020
10th Grade -
K S P L High School
Hospet, Vijayanagara04-2018
Skills
- Technical File Preparation
- ISO 13485 and QMS Implementation and Documentation
- Clinical Evaluation and Risk Management as per ISO 14971
- C-Programming
- Basics of Java Programming
- MS Excel, Word, Power Point
- Basics of MATLAB
- Human Anatomy and physiology
- Radiology
- Biomedical Instrumentation and Equipment
Projects
Major Project - Miscarriage Prediction Using Big Data Analytics and IoT
09/2023 to 05/2024
- The Project focuses on the development and implementation of a comprehensive health care monitoring system for pregnant women.
- Utilizes wearable sensors and AI Prediction Models
Mini Project - Ventilator using Arduino
04/2022 to 08/2023
- The Project was about designing a low cost ventilator providing short term ventilation for the patient during emergency conditions
- Responsibility - Hardware Development and Software Code
Mini Project - Alzheimer's Assistant
10/2022 to 03/2023
- The system was about reminding the Alzheimer Patient to Carrying out tasks and to alert the caretakers in case of emergency
- Responsibility - Hardware Development and Documentation
Mini Project - Heart Attack detection using Heart beat sensor
01/2022 to 08/2022
- The Project was on a system which operated by detecting the Heartbeat level and there by the Heart Attack
- Responsibility - Simulation and Documentation
Certification
- Communication Skills, Corporate Culture and Dynamic Skills, Integrated Program by the Centre for Innovation and Leadership, DSCE
- Certificate of Project Poster Presentation, The Oxford College of Engineering, Bengaluru
- Certificate of Project Open Day- 2023 and 2024, DSCE
- ISOI Student Chapter Certificate
- Internship Certificate - Prognosys Medical Systems Pvt Ltd
- NPTEL Online Certification - Biointerface Engineering
- Innovative and Frugal Engineering Solutions to Health Care
Hobbies and Interests
- Sketching and Painting
- Sports
- Volunteer Works
- Reading Books
Languages
- Kannada, Native Proficiency
- English, Professional Proficiency
- Hindi, Limited Working Proficiency
Timeline
Regulatory Affairs Engineer
Prognosys Medical Systems Pvt Ltd
06.2024 - Current
QA-RA Intern
Prognosys Medical System Private Limited
02.2024 - 06.2024
Intern
SpOvum Technologies Private Limited
08.2023 - 09.2023
B.E. - Medical Electronics Engineering
Dayananda Sagar College of Engineering
12th Grade -
National PU College
10th Grade -
K S P L High School
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