About GRZAN Group: GRZAN Group Limited (GRZAN) is a service provider focused on providing comprehensive technical services for global regulatory registration, clinical trials, and Inspection & Testing Guidance, etc. for medical devices and in vitro diagnostics companies. [Job Responsibilities] 1.Conduct planning and scheduling for registration projects in strict compliance with relevant regulations and industry standards. 2.Based on the established plan, guide clients in preparing official application documents, conduct document reviews, and provide them with professional advisory support throughout the process. 3.Monitor and oversee project progress and official approval timelines, promptly respond to inquiries and requirements from regulatory review authorities, and guide client companies to complete the rectification and supplementation of required materials to ensure the achievement of project objectives. 4.Assist in establishing standardized departmental and project-specific processes and document templates, as well as conducting in-depth research on product regulations and other related regulatory tasks.

[Qualifications] 1.Bachelor’s degree or above in a science or engineering field (e.g., Electronics, Automation), with preference given to candidates holding degrees in Biomedical Engineering or other medical device-related majors. 2.Comprehensive experience in medical device registration, and a certain depth of understanding of the entire certification process and regulations. 3.Familiar with the registration application process, capable of independently organizing, compiling and reviewing the technical documents required for product registration. 4.There is no barrier to reading and writing in English, and it can be used as a working language.