Experience

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  Ge healthcare

  Jun 2019 - Aug 2019

  Intern

  •Collaborated with service department team on medical devices such as CT scan, MRI, Ultrasound and Cath-Lab•Accompanied service engineers for preventive maintenance and corrective repair of medical devices•Analyzed data on customer feedback for services provided by engineers and ideate solutions to improve Net Promotor Score and customer satisfaction

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  Iziel healthcare

  Sept 2020 - May 2021

  Associate engineer

  •Received training for Design control, Process validation and Quality Management Systems of medical devices (as per US FDA requirements of 21 CFR Part 820 and ISO 13485) •Prepared Test Method Validation Plan/Report and Manufacturing Process Instructions (MPI) for US commercialization for a client•Assessed risk and impact of process and design changes to client’s medical device and created Change Assessment Forms (CAF) for regulatory review•Identified gaps in processes and documentations for a client’s AI powered software as per IEC 62304 and performed software bench testing•Conducted US FDA and EU MDR Gap Analysis and created a standard Gap Assessment template Show less

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  Usc regulatory science consulting center

  Aug 2021 - May 2022

  Regulatory affairs intern

  •Leading and managing a team for a 510k submission of a Class II medical device•Drafting design controls for regulatory submissions and analyzing cyber security issues in medical devices•Leading a team of four members to deliver summarized US FDA Medical Device and Software based regulations for client’s AI/ML based medical device•Presented a research paper on ‘Artificial Intelligence as a Medical Device in Radiology: Ethical and Regulatory Issues in Europe and the United States’ at the Regulatory Science Consulting Center Journal Club Show less

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  Dexcom

  May 2022 - now

  • Regulatory Affairs Specialist

    Jul 2023 - now

  • Regulatory Affairs Support I

    Aug 2022 - Jul 2023

  • Regulatory Affairs Intern

    May 2022 - Aug 2022