Yusi Liu
- Role
- Vice President, Regulatory Affairs and Quality Assurance (Ra & Qa) Management Representative at BioIntelliSense, Inc
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Yusi Liu
Yusi brings a decade of experience in the medical device industry across the globe…
Experience
Vice President, Regulatory Affairs and Quality Assurance (Ra & Qa) Management Representative
Jun 2019 — Present
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures minute-to-minute vital signs, physiological biometrics, and symptomatic events through an effortless patient experience. The FDA-cleared wearable device makes remote monitoring and early detection simple. Through the platform\'s advanced analytics, clinicians will now have access to high-resolution patient trending and reporting to enable medical-grade care in the home. As the Management Representative (MP) and a member of the executive management team, responsible for setting up, aligning internally and externally, and implementing the company\'s short and long-term goals and strategies. Responsibilities as the head of Regulatory Affairs and Quality Assurance- managing US and global regulatory programs- building and managing regulatory, quality assurance, and UX teams- Other Regulatory Affairs matters in different areas- BioIntelliSense\'s Quality Systems establishment and operations- Overseeing the Engineering team through a robust Agile yet 21 CFR. 820.30 compliant- design control process; converting software engineering process of a consumer electronics company into a compliant medical device design and development process conforming to IEC 62304 standard - responsible for regulatory and quality due-diligence evaluation for M&A - enabling strategic partnership with leading medical device manufacturers and distributors globally - Assisting clinical affairs operations- Assisting the company\'s privacy and security compliance programs.
Education
Shanghai Jiao Tong University
Mater of Arts (MA), User Study & Design Management
2007 — 2010
Beijing No.4 High School
High School, High school education
2000 — 2003
Beijing Institute of Technology
Bachelor of Engineering (B.E.), Industrial Design
2003 — 2007
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