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General Information

Full Name Shreyansh Sheth
Profile Summary Dynamic professional with dual master’s degrees in Biomedical Engineering and Regulatory Affairs, with a robust track record in Regulatory Affairs, Neuroscience, and Rehabilitation Research. Proven experience in leading teams, navigating complex research and regulatory landscapes, and delivering exceptional results. Committed to leveraging expertise to advance healthcare solutions with a high standard of integrity and ethics.

Summary of Skills

  • Technical: Machine Learning, Neuroscience, Embedded Systems, Circuit Design Suite, NI Multisim, NI LabVIEW, Arduino, Keil μVision, MPLAB, Advanced Statistics
  • Programming: MATLAB, Python, R, C, LabVIEW
  • Non-Tech.: Regulatory Documentation, Risk Management, Labeling, QA/QC, V&V, Auditing, CAPA, QMS, US FDA CFR, Health Canada, Canadian MDR, EMA, EU MDR, MDSAP, ISO 13485, ISO 14971, ISO 24971, IEC 60601, ISO 14155, ICH, GCP, GMP, TCPS-2, Clinical Trials, Vigilance, Project Management, Agile, 6 Sigma

Education

  • Sept.'21 - July '23
    Master of Science in Regulatory Affairs
    Northeastern University
  • July '20 - July '22
    Master of Technology in Biomedical Engineering
    Vellore Institute of Technology
  • Aug. '16 - Aug. '20
    Bachelor of Engineering in Biomedical Engineering
    Gujarat Technological University

Relevant Experience

  • Jan. '22 - Present
    Events Coordinator
    Revol Events (Toronto, ON)
    • Planned and executed several events, managing all logistics and timelines to ensure seamless experiences.
    • Worked with cross-functional teams, fostering collaboration and effective problem-solving.
    • Maintained strong client relationships, delivering customized solutions with a high satisfaction rate.
  • Apr. - July '23
    Regulatory Affairs Team Leader (co-op)
    Breegi Scientific Inc. (Boston, MA, USA)
    • Led a team of five to expedite Phase-I clinical trials for a neonatal incubator, significantly shortening the submission timeline.
    • Leveraged exceptional project management and coordination skills to ensure seamless project execution and timely completion.
    • Designed Consent Forms (ICFs), CRFs, and IB in compliance with ISO 14155 and ICH guidelines, enhancing the submission efficiency.
  • June '22 - Aug. '22
    Regulatory Affairs Specialist (intern)
    Neuro-Spinal Innovation Inc. (Mississauga, ON)
    • Spearheaded comprehensive risk management and facilitated TÜV testing, ensuring compliance with ISO and IEC standards for medical devices, which enhanced product safety and reliability by about 20%.
    • Developed and implemented various test methods for the device, meticulously crafted case reports, and authored Standard Operating Procedures (SOPs) to streamline operations and ensure regulatory compliance.
    • Maintained up-to-date technical files and design dossiers, thereby levelling up regulatory approval processes.
  • Sept. '21 - Apr. '22
    Teaching Assistant and Peer Mentor
    Northeastern University (Toronto, ON)
    • Provided guidance and support to several graduate students, assisting with academic and social adjustments.
    • Oversaw administrative responsibilities, including scheduling, coordinating events, and maintaining records.
    • Acted as a liaison, fostering communication between professor and students.
  • May - Aug. '21
    Research Assistant
    International Institute of Information Technology (Raipur, India)
    • Spearheaded experiment focused on harnessing smartphone sensors for advanced diagnostic applications.
    • Applied cutting-edge statistical data analysis and signal processing to refine vital physiological data from sensor inputs.
    • Performed data collection by extensively reviewing and synthesizing insights from several scientific papers.
  • June '20 - Jul. '21
    Biomedical Service Engineer
    Sterling Hospitals (Ahmedabad, India)
    • Conducted inspections and testing of various diagnostic, therapeutic, and life support medical equipment.
    • Performed preventive maintenance and periodic checking of devices, ensuring safety and usability.
    • Documented and maintained comprehensive records of equipment maintenance activities, adhering to strict standards.

Projects

  • 2023
    Lower Limb Exoskeleton for Kids with Scissoring Gait
    • A therapeutic approach for scissoring gait in kids with cerebral palsy.
  • 2022
    Astounding Interaction between Statistics and Human Biophysics
    • Relation of Benford's Law with human ECG waveforms.
  • 2022
    Multi-parameter Monitoring Using Smartphones
    • This project was my MTech. thesis.
  • 2021
    Stress Identification System
    • Presented at ISC-2021 Conference.
  • 2020
    Analysis of P300 ERPs and its PSD a review
    • Presented at ICAICTSEE-2020 Conference.
  • 2019-2020
    Wireless Man-Man Interfacing Rehabilitation System Hypothesis
    • Presented at ICSET-2020 Conference.

Certification

  • 2024
    • BCI and Neurotechnology Spring School
  • 2022
    • Tri-Council Policy Statement (TCPS-2)
  • 2020
    • Human Anatomy Specialization

Academic Interests

  • Neuroscience and Neurotechnology
  • Rehabilitation Engineering
  • Human-Machine Interfacing

Hobbies

  • Reading, Chess, and Rubik's Cubes