武汉招聘

RA（Regulatory Affairs） Engineer

Job Responsibilities:

Assist in implementation of registration plan for new product in China.

Assist and support in preparing, submitting and following the application for new medical device registration on time

Assist in preparation of applications for variations of marketed products and license renewals within the set time frame.

Well know professional registration knowledge on Chinese regulations or guideline

Take an active role in building and maintaining relationship with regulatory authorities

Track new regulations / standards or changes and evaluate the business impact to commercial or company.

-Responsible for the installation and troubleshooting, product demonstration and testing in the user site exclusion;

-Provide technical training of the product application for users as business needed.

Qualifications:

Bachelor degree or above, majored in medical engineering or electronic and mechanical engineering or similar background.

A minimum of 2 years experience in the regulatory affairs.

Good understanding of local regulations, guidelines and requirements and have experience in preparation of submissions.

Good oral and written English communication skills.

Good communication and team cooperation skill.

Effective problem solving, organizing and planning capabilities.

Able to travel frequently.

Primary Location：shenzhen

岗位职责：

1.协助完成在中国的新产品注册计划；

2.协助并支持准备新产品注册的申报资料，及时的递交注册申请并跟踪注册进程；

3.在设定的时间内，协助完成已上市产品的变更申请或即将到期的产品再注册申请；

4.熟悉中国法律法规或相关指南的专业注册知识；

5.积极的建立和维持与相关政府部门、专家良好的工作关系；

6.跟踪新的注册法规/标准和变化，并评价对公司的业务影响。

7.负责在现场为用户进行产品的安装、调试、故障排除和产品演示；

8.根据业务需求，为用户提供产品应用方面的技术培训。

任职要求：

1. 本科以上学历、药学及相关专业；

2. 2年以上医疗器械注册工作经验；

3. 了解中国医疗器械注册法律、法规和指南，具有医疗器械资料准备和申报注册的经验；

4. 良好的英语听说能力

5. 具备良好的沟通和团队合作能力；

6. 良好的计算机操作能力；

7. 有效的问题解决、组织和计划能力。

8.能适应经常出差

工作地点：深圳

BTL成立于1993年，如今，她已成长为世界最主要的医疗设备和美容设备供应商之一，全球拥有超过54家分部，员工1200多人，用户遍布全球。公司产品覆盖理疗设备及周边、心肺诊察系统、美容医疗设备及运动医疗设备，共30多个系列，超过120个产品，得到全球用户广泛认可。全部产品均通过CE认证、ISO机构认证和美国FDA认证。公司文化血液中的创新基因，正引领着企业在全球市场中飞速发展扩张。
公司产品覆盖三大领域，理疗设备及周边、心肺诊察系统和美容医疗设备。