Registered Engineer
classification:Social Recruitment
Recruiting Numbers: Multiple
Job Responsibilities:
1. Assist FDA, NMPA, CE registration matters, including application, planning, data preparation, declaration and tracking;
2. Participate in the R&D process of the Technical Department from the perspective of project registration, assist in handling design and development changes, and train the Technical Department on regulations and standards;
3. Responsible for external communication with external agencies related to product registration, follow up and promote product testing, registration testing, clinical trials, etc.;
4. Assist to compile and review the registration documents of FDA, NMPA, CE and other countries;
5. Keep an eye on relevant domestic and foreign laws and regulations and other relevant information at any time, and make corresponding improvements based on the information;
6. Patent application matters, various project applications at all levels, and trademark applications.

Job Requirements:
1. Bachelor degree or above, major in medicine, biology, medical device and other related majors;
2. More than one year of medical device registration work experience;
3. Be able to independently complete the medical device registration application, and be familiar with the regulations and standards of the medical device industry;
4. Experience in successful registration of Class II and Class III medical devices (active and passive), Class III medical devices are preferred; ISO13485 internal auditors are preferred;
5. Proficiency in operating WINDOWS and OFFICE office software, with good expression skills, communication skills, organization and problem-solving skills, and relevant professional English foundation.
Salary: Negotiable

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