Position Summary:

Provides regulatory support for diagnostic product development and commercial diagnostic products in China.
Coordinates CFDA local lab test, local clinical trial study and complex regulatory documents ensuring that submissions are timely and regulatory ives are met. Compiles all material required for submissions, license renewals.
Keeps informed of professional and global regulatory information. Works with governmental regulatory agencies and other third party accrediting bodies.
Researches scientific and regulatory information in order to write, edit, and review documents.

All About You

Responsibilities:

•Represents the RA function on assigned cross-functional project teams.
•Interprets and applies regulations by creating regulatory strategies for China markets.
•Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations.
•Prepares hardcopy and electronic information packages for submission to regulatory agencies.
•Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
•Reviews validation, clinical and stability protocols and reports for regulatory submission soundness.
•Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations.
•Defines, monitors and receives deliverables for submissions.
•Writes and/or edits submission documents using regulatory templates, or creates new templates.
•Assembles paper and/or electronic copies for submission.
•Monitors new and revised regulatory requirements disseminates information as directed by management.
•Interacts with regulatory agencies and third party accrediting bodies.
•Prepares internal procedures for continuous process improvement.
•Mentors junior members of the department.
•Provides regulatory guidance and/or training to external departments and partners.
•Assists with resource planning and budgeting as needed.

All listed tasks and responsibilities are deemed as essential functions to this position however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements:

•5+ year experience in Regulatory Affairs.
•Experience with an in vitro diagnostics device multi-nation company required pharmaceutical, biologics or medical device companies as native.
•Strong understanding of CFDA regulations required other international requirements - EU, Canada, Australia, Japan and Korea - preferred.
•Demonstrated ability to work independently with new, complex technologies and produce professional work products.
•Strong written and verbal communication skills.
•Team leadership skills preferred.
•Familiarity and ability to work with office automation programs and corporate database tools.
•Strong work ethic and demonstrated ability to deliver assignments on time.

Education:

•Bachelor’s degree or equivalent in healthcare or diagnostics related field required.
•Additional coursework in regulatory or quality strongly desired.


Job Deion (工作说明)
岗位概述：

为在中国的诊断类产品开发和商用诊断类产品提供监管支持。
协助中国国家食品药品监督管理局开展本地实验室检测、本地临床试验研究以及复杂的监管文件资料工作，确保及时申报提交并达到监管目标。编制申报提交、许可更新所需的所有文件资料。
保持关注并获知专业的和全面的监管信息。与政府监管机构以及其他第三方认证机构合作。
研究学习科学知识和监管信息，以便撰写、编辑和审阅文件资料。

候选人要求

岗位职责：

•代表监管事务(RA)职能部门，加入被分派的跨职能项目团队工作。
•解读并运用监管法规，为中国市场制定监管策略。
•为复杂项目制定并执行监管计划，包括新产品项目以及为现有的销售许可维护批件/执照/许可证。
•编制向监管机构提交的文件资料的纸质和电子信息包。
•为确保监管合规，就标签、制造和分析及临床研究计划等方面的事宜提供建议。
•为确保所提交监管文件资料的完善性，审阅各项验证、临床和稳定性方案和报告。
•通过变更控制评估制造流程和标签，确定对监管报表影响和遵守法规情况；
•规定、监督并接收用于申报提交的文件资料。
•使用监管文件模板或创建新的模板，撰写和/或编辑申报提交的文件资料。
•装订整理所提交文件资料的纸质和/或电子副本。
•密切关注新的和修订的监管要求，按照管理层的指示发布相关信息。
•与监管机构及其他第三方认证机构沟通交流。
•编制内部规程，实现流程持续改进。
•指导本部门的初级员工。
•为其他部门及合作伙伴提供监管指导和/或培训。
•根据需要，协助制定资源规划和预算。

以上所列的任务和职责是本岗位的基本职能；工作开展中可能需要合理完成额外的任务和职责。

岗位要求：

•在监管事务领域具有5年以上经验；
•要求具有在体外诊断设备跨国公司工作的经验，或具有在制药、生物制品或医疗设备公司工作的经验；
•要求深入理解中国国家食品药品监督管理局监管法规，熟知欧盟、加拿大、澳大利亚、日本和韩国等其他国家要求者优先；
•具有良好的工作能力，能够运用新型复杂技术独立工作并生成专业工作成果；
•优秀的书面和口头交流技能；
•具备领导力技能者优先；
•熟练运用办公自动化软件及企业数据库工具；
•具备优秀的职业道德，切实能够按时交付工作任务。

教育背景：

•要求具有医疗护理或诊断等相关领域本科学历。
•亟需参加过监管或质量管理方面课程学习的人士。

Illumina是一家领先的生命科学工具和综合系统开发、制造和营销商，其产品主要用于大规模分析遗传变异及其功能。这些系统让在几年前还不敢想象的研究得以顺利开展，使我们更加靠近实现个性化医疗的目标。随着技术的飞速进步，提供创新、灵活、可扩展的解决方案和业内领先的支持服务配套至关重要。
我们致力于通过强调互动协作、快速交付解决方案、满足客户需求来面对这项挑战。
我们的客户广泛分布于全球，涵盖了学术组织、政府部门、制药厂商、生物技术公司和其他领先的机构。