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Jahnavi Kansara

Jahnavi Kansara

Digital Content Manager

Followers of Jahnavi Kansara2000 followers
location of Jahnavi KansaraMumbai, Maharashtra, India

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  • Timeline

  • About me

    Regulatory Affairs Specialist | Medical Devices | Healthcare | EU MDR 2017/745 | US FDA | Medical Law and Ethics

  • Education

    • Dwarkadas J. Sanghvi College of Engineering

      2016 - 2020
      Bachelor of Engineering - BE Biomedical/Medical Engineering

      Activities and Societies: - Digital Content Manager – TEDxDJSCE, First ever TEDx event of DJSCE - Reporter and Head Website Coordinator – DJLit, Literary Society - Editor and Events Head – Pacemaker, Events Committee of Biomedical Dept.

    • National Law School of India University

      2022 -
      Postgraduate Diploma Medical Law and Ethics

  • Experience

    • TEDxDJSCE

      Jun 2017 - Jan 2018
      Digital Content Manager

    • Global Hospitals

      Dec 2018 - Jan 2019
      BME Intern

      - Performed daily inspection of high-end devices and equipment in addition to troubleshooting, and repair- Performed Preventive Maintenance activities and administrative activities for AMC and CMC of devices and equipment

    • Medikabazaar

      Jun 2019 - Jul 2019
      Category Intern

      - Market research for surgical equipment, cardiology, consumables, cosmetics, dental, etc.- Identification and Market Analysis for 80+ up-and-coming medical devices for B2B sales- End-to-end vendor onboarding and management

    • Technical Writing & Instructional Design Services | ibruk Consulting

      Aug 2020 - Apr 2021
      Trainee Technical Writer

      - Developed, reviewed, and updated course content on various Learning Management Systems such as BrightSpace, PFx, and Sakai.- Created 100+ effective storyboards for courses targeted towards master’s level students taught by professors from Harvard, MIT, Columbia University.- Created infographics and illustrations for courses created by a leading e-learning solutions provider.

    • Elexes Medical Consulting LLC

      May 2021 - Oct 2022

      - Enlisted FDA regulatory and quality requirements for IVD devices- Created review checkpoints for the reviewers of blogposts, marketing videos, and webinars for social media- Conducted training sessions on how to review and edit articles for the company website. - Drafted 3 Technical Documentations and 3 GSPRs for CE Submissions and authored 4 Clinical Evaluation Reports - Performed Gap Assessment and Change assessment for re-certification under MDD- Drew up Software Development Plan and SDLC templates IEC 62304: 2015-06- Well-versed with risk management activities, packaging and labeling, PMS and PMCF activities, UDI, GS1 Standards- Comprehensive understanding of IEC 60601-1, IEC 60601-1-2, ISO 10993 Series, ISO 15223-1

      • Regulatory Affairs Specialist

        Aug 2022 - Oct 2022

      • Biomedical Engineer - RA/QA

        May 2021 - Jul 2022

    • Lexium Consulting

      Apr 2024 - now
      Executive - Regulatory and Quality

  • Licenses & Certifications

    • Finance for Everyone: Decisions

      Coursera

    • Healthcare Marketplace

      Coursera

    • Bridging healthcare and society

      Coursera

    • TECH MeD: Transdisciplinary Education for Critical Hacks of Medical Devices

      Coursera

    • Technical Writing

      Coursera

  • Volunteer Experience

    • Volunteer

      Issued by Robin Hood Army on Aug 2021
      Robin Hood ArmyAssociated with Jahnavi Kansara

    • Writer

      Issued by Medium on May 2021
      MediumAssociated with Jahnavi Kansara

    • Volunteer

      Issued by Project Surat on Mar 2022
      Project SuratAssociated with Jahnavi Kansara