Experience

medmix

• Switzerland
• Medical Device
• 200 - 300 Employee

• Quality Assurance Engineer

  • Aug 2023 - Present

  Georgia, United States

• Quality Assurance Intern

  • May 2023 - Aug 2023

  Georgia, United States



​RusCert Technology Co., Ltd.

• Regulatory Affairs Consultant

  • May 2021 - Aug 2023

  Taipei, Taipei City, Taiwan - Oversaw the completion of over ten projects that included active, non-active, and SaMD devices, such as medical beds, acne patches, heating wire for ventilators, as well as urine monitoring systems. All projects were completed successfully and all obtained 100% certifications of approval for FDA 510(K) clearance and CE marking - Coach manufacturers to establish DHF and DMR in compliance with ISO 13485 standards and FDA Quality System Regulation, all manufacturers will be able to pass the… Show more - Oversaw the completion of over ten projects that included active, non-active, and SaMD devices, such as medical beds, acne patches, heating wire for ventilators, as well as urine monitoring systems. All projects were completed successfully and all obtained 100% certifications of approval for FDA 510(K) clearance and CE marking - Coach manufacturers to establish DHF and DMR in compliance with ISO 13485 standards and FDA Quality System Regulation, all manufacturers will be able to pass the audit and file their documents successfully - Develop technical documentation, including risk management files (risk management plans, RACT, and reports), and clinical evaluation plans and reports, compliance FDA 510(K) clearance and CE marking

• Regulatory Affairs Specialist

  • Aug 2019 - Apr 2021

  Taiwan - Supported clients' compliance with the US, European, and Taiwanese medical device regulations, including compliance with 510(K) clearances, CE markings, or IND approvals - Established risk management files (plans, hazard traceability tables, and reports) for devices that have a Low or Medium Risk per ISO 14971:2012 / 2019 - Developed clinical evaluation plans and reports for low to medium risk medical devices



Taipei Medical University

• Hospitals and Health Care
• 500 - 600 Employee

• Graduate Research Assistant

  • Apr 2021 - Feb 2022

  Taiwan - Facilitated communication between Academia, Ministry of Foreign Affairs, and the university, performed administrative tasks, summarized research, and conducted literature reviews related to biotechnology and health policy, contributed to a smooth, and successful completion of the government research project



TCY Cosmetics Co., Ltd.

• Operations Management Associate

  • Aug 2014 - Dec 2018

  Taiwan Managed a team of three people Legal Affairs: - Finalized 40 complex commercial contracts monthly, setting precedent for standard template across organizations in four international locations - Filed and obtained 15 trademarks & 1 patent per year, securing corporate intellectual property rights with 90% initially successful rate - Provided lawful advice to companies regarding their daily business activities, holding one-on-one meetings with department heads and the CEO at… Show more Managed a team of three people Legal Affairs: - Finalized 40 complex commercial contracts monthly, setting precedent for standard template across organizations in four international locations - Filed and obtained 15 trademarks & 1 patent per year, securing corporate intellectual property rights with 90% initially successful rate - Provided lawful advice to companies regarding their daily business activities, holding one-on-one meetings with department heads and the CEO at least twice a week - Provided legal advice to companies regarding their daily business activities, holding one-on-one meetings with department heads and the CEO at least twice a week to address +5 disputes and averting liability Human Resources: - Revolutionized recruitment efforts by increasing yearly recruitment by 33% through establishing 4+ recruitment channels and conducting 400+ interviews/year - Directed resource management to facilitate flow of funds from Employee Welfare Fund, successfully overseeing 10+ activities with 100+ employees and achieving 89% satisfaction rate - Supervised employee liaisons to ensure smooth workflow during organizational expansion, facilitating hiring of 50+ professionals Show less