Summary of Duties and Responsibilities

主要职责

 

Establish, maintain and execute appropriate registration plan on the responsible pipeline, based on project priority and lead time.

对所负责的产品线，根据项目优先程度和所需的时间，建立、维护并执行合适的产品注册计划。

Forecast and maintain an appropriate registration project budget plan to the responsible pipeline.

对所负责的产品线，预测并维护合适的注册项目预算表。

Take over the whole procedure of registration, including sample ordering, testing, dossier preparation, submission, evaluation and license obtaining.

负责产品注册的全过程，包括定样品、检测、资料准备、递交、审评和获取注册证。

Coordinate, compile, and submit new device applications to the regulatory agencies. 

协调、整理新设备注册申请并向监管机构进行提交

Review, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation.

对须提交的注册文件进行评估、编辑和校对。实时跟进注册文件的状态和进展情况。

Ensure compliance with authority regulations and interpretations. 

确保注册工作符合监管法规及相关解释。

Prepare responses to authority's questions and other correspondence. 

就如何回复监管机构的问题及其它质询进行准备。

Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines. 

收集并整理法规信息及相关指导意见以使注册申请能够符合要求。

Provide solutions to a variety of problems of moderate scope and complexity. 

为特定范围及复杂程度的各种问题提供解决方案。

Organize and maintain reporting schedules for new device application.

组织和确保对新设备申请的进度进行汇报。

Maintain and renew of existing registrations.

现有注册的维护和更新。

Involved in related product inspections and coordinate with international teams to solve related issues.

负责产品检测并与国外同事协调解决检测中出现的问题。

Assist in preparation and review of labeling, SOPs, and other departmental documents.

协助对标签、流程文件及其它部门文件进行准备及评估。

Participate as an active team member of project teams as required.

必要时作为项目组成员参与工作。

Implement the Regulations for labeling, organize, coordinate and monitor the implementation of Instructions for use and labels of medical devices, and assist in the internal and external supervision, inspection and audit.

贯彻执行说明书及标签的法规要求，组织、协调并监视医疗器械说明书和标签实施，协助内外部监督、检查、审核。

Maintenance of medical device product qualifications, including the establishment of Oracle product master data, internal and external maintenance of UDI information, and the local extension and implementation of changes for foreign product BOMs and materials.

医疗器械产品资质维护，包括Oracle产品主数据的建立，UDI信息的内外部维护，国外产品BOM及物料的本地化拓展及变更实施。

Initial and periodic qualification audits of medical device suppliers and distributors, as well as the maintenance of related quality agreement templates.

医疗器械供应商及经销商首营及年度的资质审核，以及相关质量协议模板的维护。

 

 

EDUCATION

 

Bachelor above degree majored in medical, pharmaceutical, biological, immunology or related specialties.

本科及以上学历，电气、机械、计算机、生物医学或相关专业

 

QUALIFICATIONS & EXPERIENCE

 

        More than 5 years regulatory affairs and related QA working experience in medical device field

相关医疗器械注册事务及相关质量管理工作经验5年以上

Familiar with imaging, surgical or IVD products preferred

熟悉影像、外科设备及耗材或体外诊断设备和试剂者优先

Working background in MNCs preferred

跨国企业工作背景优先

Good communication and interpersonal skills

良好的沟通和人际交往技巧

Strong attention to details, be very careful and responsible

注重细节，认真负责

Knowledge of Agile PLM software and Oracle is an advantage

对Agile和Oracle有使用经验

Fluent English (verbal and written forms)

流利的英文（口头及书面）