Bachelor's degree or above, majoring in biology, medicine, clinical laboratory, medical English, export medical regulations or related majors; 1-3 years of international registration experience, with strong English listening, speaking, reading and writing skills; Familiar with relevant regulatory knowledge of medical device product registration and certification, such as clinical application of related products, FDA, CE certification, and overseas medical device product certification or registration processes; Have good management, communication and problem-solving skills, as well as good negotiation skills; Strong pressure resistance, diligent, self-disciplined, with excellent learning ability and self-motivation; recognize and accept the company's corporate culture. Formulate product registration plans based on international business strategies and product status; Conduct international product certification or corresponding registration and certification in accordance with the regulations of the export country; Maintain the validity of international product registration certificates, and judge and implement registration changes; Sort out, file and manage registration documents and certificates; Candidates with FDA registration experience are preferred.
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