1. Responsible for the domestic and international registration of the company's medical device products, and formulate a medical device registration plan;
2. Responsible for organizing the preparation, sorting and submission of registration materials, tracking the registration process, and ensuring that the certificate is obtained on time;
3. Responsible for the organization and implementation of product registration inspection and clinical evaluation;
4. Responsible for external communication and coordination with external agencies (testing agencies, announcement agencies, and government authorities) related to product registration, and solve problems that arise during the review process;
5. Responsible for the update of relevant domestic and foreign registration regulations and standards;
6. Responsible for new product registration, registration certificate change and registration renewal when the registration certificate expires, including collecting and sorting out information, writing and reporting registration documents, preparing samples and materials for inspection;
7. Other affairs arranged by superiors.
1. Bachelor degree or above, major in biotechnology, biomedicine, chemistry, medical equipment, etc.;
2. 3-5 years or above experience in medical device product registration, familiar with ISO13485 system, with ISO13485 internal auditor certificate is preferred;
3. Familiar with the second and third category medical device registration process,
4. Clear mind, quick thinking, good oral and written expression skills, strong project management skills and communication and coordination skills;
5. Strong English expression and reading ability, can independently compile English registration documents and materials, and be familiar with the EU CE registration process and FDA registration process;
6. Work initiative and strong ability to withstand pressure.
1. Responsible for the pre-processing and assembly of product parts;
2. Carry out product assembly and maintenance in accordance with technical and process requirements;
3. Assemble the product in accordance with the requirements of the work instructions and welding process documents;
4. Responsible for the cleaning of the production workshop, the configuration of disinfectants and the cleaning of containers;
5. Responsible for filling and filing batch production records.
1. Major in electronics and mechanics, college degree or above
2.1 years of electronic and mechanical product assembly, maintenance experience is preferred
3. Proficiency in completing assembly work in accordance with SOP;
4. Good health, good character, good writing spirit, and obey management.
1. Responsible for finished product warehousing and delivery
2. Responsible for receiving, applying for inspection, and warehousing of incoming materials
3. Assist in production picking to ensure production
4. Responsible for timely handling of returned materials
5. Responsible for the 6S finishing of the warehouse environment to ensure the warehouse temperature and humidity
6. Other temporary work
1. High school degree or above, hard-working
2. Work experience in manufacturing logistics is preferred
3. Living in Tanggu, Development Zone, Hangu, Eco City is preferred
1. Develop a purchase plan according to the demand plan, make purchase orders, track the arrival of the order, send inspection and warehousing progress;
2. MRO supplier and contract management, price comparison and negotiation, and contract signing;
3. Notification of defective products return and exchange and follow-up work;
4. Calculate and summarize daily data such as orders, arrivals, and payment details;
5. Responsible for the collection, analysis and statistics of procurement data;
6. Perform temporary work arranged by superiors;
7. Perform monthly supplier reconciliation and payment settlement;
8. Supplier information update;
9. Conduct business communication and coordination with suppliers;
10. Cooperate with relevant departments to deal with material quality and other issues.
1. College degree or above, science and engineering professional background, three years or more of manufacturing materials and MRO procurement experience, electronic components, machined originals, medical industry background is preferred.
2. Strong execution, clear organization, quick thinking, able to withstand greater work pressure; good communication skills; skilled use of various office software.