苏州招聘

Responsibilities:
1. 负责相关法规活动，确保销售产品符合法律法规要求；
Be responsible for relative regulatory activities to ensure sold product meets requirements of laws and regulations.
2. 负责本公司质量体系维护和持续改进，包括但不仅限于以下方面和项目
Lead the Quality Management System maintenance and improvement activities and projects including but not limited to below
1) 参与风险管理活动；负责纠正预防措施管理，负责对各种来源的数据进行趋势分析；
To participate in risk management; to manage corrective and preventive actions, and be responsible for conducting trend analysis about the data from various sources;
2) 负责内部和外部质量审核；
Be responsible for internal and external quality audit;
3) 负责相关体系文件的编制、审批和改进；
Be responsible for establishment, review, approval and improvement of quality management system documents;
4) 控制特殊过程确认；
To control validation of special process;
3. 及时了解和掌握器械相关法规现状，并及时在公司内部进行宣传及贯彻；
Timely understand and master the current status of relative regulation about medical devices and propaganda and implementation in the company;
4. 负责协调和支持相关产品注册工作,包括但不仅限于：中国SFDA, 美国 FDA，欧洲及其他国际市场。针对当地法规要求建立和维护相关程序，比如：客户投诉、上市后监督；产品标识标识等。
Responsible for coordinating and supporting relative medical device registrations, including but not limited to China SFDA, US FDA, EU and other international markets.
5. 与培训及相关职能部门一起计划、组织和提供公司相关法规培训及教育。
Provide and support regulatory compliance training and education to the organization
6. 针对公司运营遇到的各种情况及新业务提供法规指南和支持。
Provide regulatory guidance to various issues and new businesses for the company.
7. 完成亚洲区法规和质保总监指派的临时任务。
Finish temporary task assigned by Director, Regulatory Compliance and Quality Assurance, Asian.

Requirements:
1. 本科以上学历，8年以上QA部门或法规部门工作经验；3年以上团队建设及领导经验。
Bachelor degree or above, more than 8 years’ working experience in QA or RC; 3 years or more as team leader to develop and lead team;
2. 熟练掌握ISO13485、ISO9001质量管理体系，了解SFDA, FDA或CE法规要求。
Familiar with ISO13485, ISO9001 quality management system and SFDA, FDA or CE regulatory requirements for Orthopedic instruments.
3. 较强的协调和沟通能力；能与总部、其他姐妹公司及公司内部部门间有效沟通；具有医疗器械产品注册经验的优先。
Be strong and effective communicator with Corporate, other sister companies under Corporate, as well as different functions in the company. Prefer to have product registration experience by interacting with SFDA.
4. 了解过程确认 、ISO14971和ISO2859或类似统计原理及知识，具备质量管理体系文件编制、审批的经验。具有项目管理经验的优先。
Be familiar with process validation, ISO14971 and ISO2859. Have experience of establishing and approval of quality management system documents; Prefer to have project management experience.
5. 良好的中英文双语能力及计算机(Microsoft Word, Excel, PPT, Project etc) 熟练操作能力。
Good command of Mandarin and English in listening, speaking, reading and writing, and proficient in MS Office SWs (Word, Excel, PPT, Project etc).

盛才猎聘（全称“苏州盛才管理咨询有限公司”）是全球新能源领域领先的专业猎聘机构，2008年成立于素有”人间天堂“之美誉的苏州，总部毗邻距今已有2500年悠久历史的平江路历史街区。

作为新能源猎聘领域的领导品牌之一，盛才猎聘始终秉承"惟精惟一"的经营理念，矢志不渝地致力于为全球范围的光伏、储能、售电、新能源汽车等新能源领域的企业客户提供优质的中高端人才招聘服务。盛才猎聘的服务客户满意率超过95.8%，并多次荣获"***猎聘供应商"、"***战略合作伙伴"等殊荣。

盛才猎聘也是国内最早从事海外猎聘的猎头机构之一。8年来，为我们的客户在全球30多个国家和地区（美国、墨西哥、巴西、德国、英国、瑞士、澳大利亚、巴基斯坦、印度、泰国、马来西亚、越南、菲律宾、尼日利亚、日本、南非等）成功猎聘300多位中高端人才。

愿景： 成为全球新能源行业第一猎聘品牌
使命： 为全球新能源客户提供最优质的猎聘体验
价值观：诚信、正直、忠诚、包容、勤奋、敬业、认真、责任
经营理念：惟精惟一、专业专注、远见创新