[深圳]深圳市德诺医疗控股有限公司

Job Responsibilities:

1. Be responsible of the medical device registration and approval in correlative area, including regulation research, organize registration activities, create regulatory plan, create and submit file;

2. Provide regulatory guidance and solution to other departments where RA input are required;

3. Communicate with consultant, CRO and Competent Authorities in the EU, assist to solve problems in approval process.

Skills and Requirements:

1. Master’s degree or above in related scientific discipline; Medical, pharmaceutical, bioscience and engineering background is preferred;

2. Adapt to go on international business trip, international student is preferred;

3. Have a logical mind and ability to analysis and solve problems, and have stronger ability for coordination and communication;

4. Have excellent communication and presentation skills in English.

The company will provide good pay & benefits for the right candidates.

注册工程师-国际应届生

岗位职责:

1. 负责医疗器械在全球相关区域的市场准入和注册工作，包括法规调研，注册活动组织，注册资料编写、收集和递交；

2. 负责日常法规输入；

3. 负责和欧洲顾问、CRO及监管机构的联络沟通，协助解决审批中的问题。

岗位要求:

1. 硕士及以上学历，生物、电子等理工科专业优先；

2. 能适应国际出差，国际生优先；

3. 具备良好的逻辑思维和分析解决问题的能力，较强的协调组织和沟通能力；

4. 具备熟练的英语沟通和表达能力。

薪资福利面议