Experience

Vorpal Technologies K.K.
• Japan
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Senior Project Manager

  • Jul 2023 - Present


MCRA

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Senior Associate, Cardiovascular Regulatory Affairs

  • Mar 2023 - Present

• Associate, Cardiovascular Regulatory Affairs

  • Feb 2021 - Mar 2023

  Develop and execute regulatory product and support services for cardiovascular medical device client companies, including:- Regulatory Submissions (Q-subs, 510(k), De Novo, PMA, IDE)- International Regulatory Submissions- Regulatory Strategy, Analysis & Development- Formal Recommendations on Product Development and Pre-Clinical Testing Considerations



Organoid Therapeutics

• Biomedical Engineer and Regulatory Specialist

  • Mar 2020 - Dec 2020

  Perform Regulatory and Quality Assurance activities such as pre-submission development, product specification documentation and quality management systems specifically, audit procedures. Perform Regulatory and Quality Assurance activities such as pre-submission development, product specification documentation and quality management systems specifically, audit procedures.


Center for Medical Innovation
• United States
• Medical Equipment Manufacturing
• Graduate Student Fellow

  • Aug 2019 - Aug 2020