Nora XI, RAC

Had a lot of fun connecting young entrepreneurs in Biotech/Medtech/Pharma field with industry professionals, regulatory/legal experts and venture capitals :)

1. Developing a centralized submission tracker for the whole diagnostics RA team to tracking all the regulatory submissions and approvals. Effectively communicating with team members, fostering collaboration and actively incorporating their ideas and suggestions. 2. Supporting the international registration process for three electronic medical devices in India and three in-vitro diagnosis kits in Kuwait.

1. Primary compiler of two 510(k) initial submissions and RTA hold responses for a fingertip pulse oximeter and an air-compression therapy recovery system (K230500). Responsibilities included: identifying predicate devices, drafting 510(k) submission reports, translating labeling information from Chinese to English, revising software documents, etc. 2. Supported transition from EU MDD to EU MDR for Class Is and Class IIa devices. Responsibilities included applying basic UDI-DI and EU account for clients, identifying device categories and applicable standards, revising and reformatting risk management and usability evaluation documents adhere to EU MDR regulations, researching and writing clinical evaluation documents through literature research, analysis and summary, as well as translating and reviewing labeling information from Chinese to English. 3. Formulated RTA reply documents for an active medical device and served as primary point of contact for the FDA to ensure effective communication during two virtual conferences in the interactive review stage. 4. Developed a performance test plan for subject device based on previous FDA RTA feedback of similar devices, and reviewed the resulting performance test report. 5. Led and/or facilitated interactions of Chinese manufacturers with international Clinical Research Organizations and university to initiate clinical studies in USA. 6. Received regulatory training on principles and global regulations of IVD products, IEC 60601-1-2 standard, ISO 10993 series standards, and UDI implementation.

1. Led team to research and propose product classification and prepared a draft Request for Designation (RFD) for a novel dental gel for submission to FDA. 2. Supported an internal MDSAP audit for 21 CFR 820 and ISO 13485 compliance, and compiled the audit report for purchasing control and Production & Process Control. 3. Researched applicable cybersecurity strategies according to the latest FDA draft guidance for a wireless gamma probe unit. Reported the identified potential added characteristics to company CEO to fulfil FDA requirement

1. Using the decellularized natural cartilage as original material to develop magnetic microrobots and finding new strategies for treating Osteoarthritis. 2. Involving in the scientific research of fibroblasts and bone marrow mesenchymal stem cells, master stem cell culture and staining techniques.