Job Responsibilities:
1. Collaborate with the Marketing and R&D departments to help define the product roadmap and R&D plan, and to clarify the product definition.

2. Conduct clinical communication to gather and analyze user needs, accurately define product requirements, and break them down into detailed specifications.

3. Deeply engage in the R&D process by communicating and clarifying clinical needs to the R&D team and reviewing R&D design proposals.

4. Collaborate with the regulatory affairs department on product submission for testing, clinical trial protocol design, clinical trial execution, and the preparation of certain clinical trial documentation;

5. Participate in clinical research collaborations, submit project proposals, and follow up on related research projects;

6. Participate in the preparation of relevant project documentation.

Job Requirements:
1. Possess a science or engineering background with experience in clinical collaboration with hospitals; bachelor’s degree or higher.

2. Preference will be given to candidates with research experience in medical robotics or product definition experience, as well as experience with AI-related products.

3. Strong capabilities in product requirements analysis and copywriting;

4. Possess innovative thinking;

5. Strong learning and adaptability; excellent skills in literature and information retrieval; high sense of responsibility; able to handle work pressure.

6. Demonstrates strong teamwork skills, clear communication and articulation, and excellent written English proficiency.

Please send your resume to: hr-02@hicren.com

Job Responsibilities:

1. Responsible for the development and performance optimization of active consumable products;

2. Responsible for the design transfer and implementation of active consumable products;

3. Responsible for preparing documentation for active consumable products and risk management documents;

4. Other tasks related to active consumable products.

Job Requirements:

1. Bachelor’s degree or higher in Mechanical Design or a related field;

2. Candidates with experience in the development of active consumables and similar products will be given priority.

Please send your resume to: hr-02@hicren.com

Job Description:

1. In accordance with the annual product inspection and registration plan, monitor and follow up on product development progress to ensure timely completion of the plan;

2. Responsible for managing product inspection and registration-related documentation;

3. Responsible for product registration applications, including initial registration, registration amendments, and renewal of registration;

4. Responsible for organizing and submitting product registration documentation;

5. Responsible for communicating with the registration and approval authorities, coordinating the resolution of issues arising during the registration process, and ensuring timely acquisition of the registration certificate;

6. Assist in organizing the rectification of registration materials, develop a rectification plan, and follow up on its implementation;

7. Responsible for product registration testing and participate in the development of product technical requirements;

8. Responsible for communicating with the competent inspection authority, coordinating the resolution of issues arising during the inspection process, and ensuring timely receipt of the inspection report;

9. Responsible for collecting and updating laws and regulations related to medical devices, and for organizing timely study and training sessions;

10. Maintain qualification certificates related to the product registration certificate, such as the manufacturing license, etc.;

11. Assist in conducting product quality system audits and implementing corrective actions;

Timely and efficient completion of other tasks assigned by superior leaders.

Job Requirements:

1. Minimum educational requirement: Bachelor’s degree or higher;

2. Professional Requirements: Relevant science and engineering majors;

3. Work Experience: Recent graduates are also eligible; candidates with registered filing experience will be given priority.

4. Knowledge and Skills:

4.1 Professional Knowledge: Familiarity with the registration application submission process, sample submission for testing, and relevant laws and regulations;

4.2 Foreign Language Requirements: Good command of English;

4.3 Computer Requirements: Proficiency in office software such as Microsoft Office;

5. Competencies and Qualities:

Required qualifications: Strong writing skills and the ability to independently prepare technical documentation.

Strong communication and organizational coordination skills, as well as planning and execution capabilities;

Possess a certain level of judgment and decision-making ability;

Possesses strong stress tolerance;

6. Qualification requirements: humility, proactiveness, enthusiasm, and a strong desire for self-improvement;

Other: Willing to work overtime, compliant with management, and strong team player.

Please send your resume to: hr-02@hicren.com