RA Engineer

工作概要:
This position is responsible for developing an******** companyregulatory policy an********, preparing submission documents in a timelyan******** quality manner for obtain medical device registrationan******** license.这个职位主要负责实现为取得公司医疗器械产品注册证和生产许可证，及时、高质量地建立和执行相关监管政策和程序、相关文件的准备和提交。

岗位职责:
1. Response to gather all medical regulation an******** new projecttransferring (including cFDA, dental industrial an******** on)负责收集和更新与公司业务和产品相关的相关法律法规 （包括药监局，牙科行业等等）
2. Drive complete process of product registration an******** licensewith the local FDA an******** Chinese Government departments负责与地方药监局和其他政府部门合作，全权负责完成公司产品注册和生产许可证流程
3. Develops an******** strategies an******** plan for the timelyapproval of regulatory applications. Provide timely updates tomanagement on changes in regulatoryrequirements.根据国家法规的最新要求，制定和执行产品注册的战略和计划。 并根据国家法规要求的变更及时的更新相关的管理
4. Assist in the development an******** of policy an******** forregulatory affairs an******** to establish a compliant culture withinthe organization. 协助制定并推进法规事务及合规性政策与程序，从而在组织内部建立合规文化
5. Response for the production re-registration an******** license reviseperiodically负责产品注册证的定期再注册和生产许可证的更新
6. Ensure that regulatory authorities’ requirements are met for productsengineere******** manufactured. 确保所有开发和生产的产品符合相关的法规要求
7. Along with project eng******** ensures that each product complieswith local, reg******** and/or national reg******** safety, an********require******** before product are delivere******** the customer.和项目工程师合作，确保所有的生产和销售的产品符合本地的，区域或国家的注册、安全法规及其他的要求
8. Develop changes as require******** label******** manufactur********market******** engineering an******** protocols for regulatorycompliance. 针对产品标签、制造流程、市场、工程和临床的要求，开发相关工程变更以达到法规合规的要求
9. Ensure that appropriate tracking an******** systems existan********.确保所有产品的跟踪和控制系统的执行和有效性
10. Response for the data collect******** analysis an******** to cFDA,including tracking product events, complaintsan********，分析并向药监部门的定期汇报，包括跟踪产品活动、投诉与召回

岗位要求：
1. Over 3 year experience in domestic Medical device registration3年以上国产医疗器械产品注册经验
2. Be familiar with cFDA regulation an********process熟悉医疗器械相关行业法律法规和注册流程
3. Fluent English skill both in oral an******** 熟练的英语口语和读写能力
4. Experience in product R&D in preferred. 有相关产品研发经验者优先