Tina Chou

Medical Device Regulatory Affair Specialist

  Hello, this is Tina Chou who is very pleased to have this chance to introduce myself, hopefully below content will help you know me more.

  I graduated from English Department at Wenzao Ursuline College of Languages in June 2007. I majored in English and minored in Germany. Except for various language courses, I was also interested in business thus I elected International tourism English, Theory of advertisement, News writing, Marketing, Business administration and Human resource management...etc. to improve the other knowledge for using in the workplace. During the school year, I was involved in many extracurricular activities, clubs, and competitions and have many fruitful results. I was very used to doing my tasks efficiently in a limited time.

  My first job after graduating is as an international trade specialist for exporting the steel product of China Steel, CHSC, YUSCO and Yieh-Phui Steel to Southeast Asia, Australia, Japan and Oceania, etc. I had been working 6.5 years for this first job very hard to learn and enrich the experience of international trading. In addition, I also took a 1 month's trading course held by the International Trade Institute, 1.5 years for Japanese course and passed the JLPT N3 test. At the same time, I was the sales chief to train the new trading specialists, assign and supervise their work. 

  My second job is as an international trade specialist for importing European, USA, Japan, China & Nepal ophthalmic medical equipment as the authorized distributor. Except for international trade tasks, I was also responsible for product registration affairs. I had to apply for Quality System Documentation (QSD) and register a product importing license for foreign manufacturers for importing legally. This has allowed me to promote more practical experiences regarding registration affairs and I also participated in many regulatory courses in the past four years. Through the coordination between the foreign manufacturers and the TFDA, I have full understanding for each registered product from the design, function, processing and inspection methods...etc., and can communicate with the sales department to strengthen the product's advantages and marketing methods. At the same time, I also need to report the customer's feedback, problems, and customer complaints to the foreign original manufacturers to assist both parties to identify the problem and provide the best solution. Moreover, there were also more than two domestic exhibitions every year, which increased the experience of preparing for exhibitions, attending exhibitions and hospitality for foreign guests.

  My 3rd job was the quality & regulatory specialist of NCKU's startup for medical devices. With my previous practical experience of registration, I have established and maintained the operation of ISO13485 for the company. The goal is to obtain a listing license in the United States, Europe, and Taiwan in the future. In order to have a further understanding of the establishment and update of regulations, I took intensive training during my tenure and participated in courses such as ISO13485, US FDA regulations, internal auditor training, and European MDR regulations. 

  The last job is as the regulatory affair specialist of Honest Medical Equipment Macau Co., Ltd. Taiwan Branch, mainly handling the license registration and import affairs for the foreign medical device & cosmetics products which are authorized to sell. In addition, I also assist to gather the related regulatory and competitive products for the new product of R&D Dept.

  I like to engage in the work of communication between people, touch different national conditions and cultures, help people to solve problems and improve the quality of life or optimize the experience of use. I hope to do sales for various fields and various products for activating Taiwan's commercial economy activities. With a well-experienced in international trade and language skills, I will do my best to integrate into your company's operating system in the shortest time after training for helping your company to launch products that are closer to the needs of users and provide better services to customers. 

  [email protected]

  Tainan City, Taiwan