EN CN

Job Title:International Registers Engineer

Location: Nanjing
Release Date: Jan 2021

Apply

View Details

Responsibilities:
1. Responsible for the registration declaration of medical devices at home and abroad;
2. Assist in the registration process of medical devices related to inspection matters, such as type testing, bio-compatible testing, ROHS and so on; Responsible for sending inspection and communication and coordination with institutions and inspectors to help solve problems until the test is qualified;
3. Responsible for communicating product certification and system certification with the announcement body;
4. To assist in the processing of other types of documents for product market access;
5. Prepare and update CE technical documents;
6. Relevant registration regulations, information collection, sorting;
7. Assist and complete other work tasks assigned by superiors.

Job requirements:
1. Bachelor's degree or above in biology, medicine and engineering, more than 5 years of relevant work experience;
2. Familiar with foreign medical device certification and declaration process and related laws and regulations, foreign medical device registration experience;
3. Good communication skills, coordination skills and writing skills;
4. Work conscientiously and rosery, rigorous, meticulous, proactive, organized, with strong analytical and problem-solving skills, to ensure high-quality and efficient implementation of the project;
5. Good English, CET level 6 and above is preferred.

Job Title: Clinical Project Manager

Location: Nanjing
Release Date: Jan 2021

Apply

View Details

Responsibilities:
1. According to the company's development plan, develop clinical trial project plans and budgets, establish and implement clinical operations the related systems and processes of clinical operations;
2. Responsible for managing and supervising the execution of the company's clinical programs to ensure that clinical trials are completed efficiently as planned;
3. Responsible for evaluating, selecting and establishing partnerships with clinical trial bases and CRO, and effectively monitoring and managing them to ensure that they deliver projects on time and at high quality to complete clinical trials;
4. Proactively and coordinately address issues that occur during clinical trials to ensure that clinical projects are conducted in accordance with GCP, SOP and local laws and regulations;
5. Manage and build clinical research teams to assist team members in establishing and maintaining good relationships with all partners;
6. Responsible for clinical trial summary, review, approval and organization of clinical meetings.

Job requirements:
1. Bachelor or above degree, major in clinical medicine related, 10 years of relevant working experience;
2. Familiar with the regulations and the current situation of clinical research and development at home and abroad, proficient in the whole process of clinical trials, with at least 8 years of clinical work experience, more than 5 years of clinical project management work experience, responsible for a complete clinical research project experience, foreign enterprises and domestic pharmaceutical companies’clinical operation work experience is preferred;
3. Good communication and organizational coordination skills and team spirit, strong analytical skills;
4. Proficient in English, proficient in GCP regulations and familiar with the formulation and standardization of all clinical trial documents.

Job Title: Embedded Software Engineer

Location: Nanjing
Release Date: Jan 2021

Apply

View Details

Responsibilities:
1. Participate in the development of the company's R&D projects, responsible for hardware equipment software-driven writing and later testing work;
2. Writing relevant embedded software, involving low-power Bluetooth, Wi-Fi and other products software work;
3. According to the needs of the product's hardware interface design, software code design;
4. The writing of the complete technical documentation, production output.

Job requirements:
1. Electronics, computer, automation and related undergraduate degrees or above;
2. Embedded software development experience: proficient in C language, proficient in the use of Keil, IAR and other IDEs, familiar with MCU commonly used peripheral circuits, signal amplification, drive and other hardware principles, familiar with the use of MCU architecture and application development, UART, I2C, SPI, USB, CAN and another common interface bus;
3. Master the BLE protocol stack, wifiSDK module development work, master TI, Le Xin and other companies’SDK, such as ESP32/8266 TICC2540 development work;
4. Fluent in an embedded real-time operating system, such as UCOS-II, FREERTOS, etc. priority or familiar with the embedded Linux cross-compilation environment, familiar with the Linux kernel, with Linux SPI/I2C/UART/USB bus application experience.