上海招聘

主要工作职责 Key Responsibilities: (概括关键职责、每项职责所要达成的结果/primary deliverables of roles)

1. 作为IVDR项目专家，负责推动IVDR项目在工厂的实施。 Act as IVDR project expert, responsible for drive IVDR project implementation in site.

2. 与客户及总部积极合作，识别IVDR法规相关适用要求。在过程中，深度理解识别出的改进措施，评估相关风险，提供专业的建议。 Work closely with customer and BU, identify IVDR related requirements for site. Deeply understand the improvement requirements and actions, evaluate risks and provide professional improvement advices during the process.

3. 支持项目组长，积极协调内部，参与制定项目方案，满足合规要求及客户需求。 Support project leader, coordinate actively within site to set up project plans that able to meet compliance requirements and customer needs.

4. 推动项目按时完成，及时跟踪测量项目进度，跟进项目活动/任务，汇报结果及异常情况。 Drive project on time completion, on time track and measure project progress, follow up project activities/tasks, report output and abnormal. 5. 按照客户需求及项目计划，及时、准确地向客户提供相关资料递交、更新以及内部变更信息。 On time and accurately provide customer with related documentation, updates and site internal change information base on project plan and customer needs.

6. 参与内外部相关沟通会议，电话会议。按要求准备各种会议资料，报告纪要等。 Participate in external and internal related communication meeting, conference call, prepare information/documentation ahead and summarize meeting report/output and etc.

7. 完成上级安排的其他任务。 Undertake other tasks that assigned by superior.

任职条件Qualifications: (该职位任职者所需具备的成功要素/ Key success factors the job holder should have) ·

文化程度Education: 1. 大学本科以上学历。 Bachelor’s degree or above. ·

任职经验Working Experience:

1. 3年以上制药、医疗器械、 IVD等制造行业经验。 3 years or above manufacturing experience in pharmaceutical, medical device, IVD or healthcare industries.

2. 具有法规或质量，及项目管理相关工作经验。 Relevant working experience in regulatory or quality and project management. ·

专业知识/技能Professional Knowledge/Skill:

1. 熟悉ISO13485, GMP, 21CFR等相关法规。 Familiar with ISO13485, GMP, 21CFR and other related regulatory requirements and guidelines.

2. 熟悉IVDD和IVDR法规。 Familiar with IVD and IVDR. ·

计算机及外语水平Computer & Language Skill:

1. 优秀的英语能力。 Excellent command of English.

2. 优秀的电脑操作和MS Office软件能力。 Excellent computer and MS Office software skills.

3. 优秀的写作能力，表达能力。 Excellent skills of writing, presentation skills. ·

能力要求Competency:

1. 自律、自我激励和良好的工作道德。 Self-disciplined, self-motivated and with good working ethic.

2. 良好的团队合作和沟通/协调能力，能妥善协调相关工作。 Good teamwork and communication/coordination skills, be able to coordinate related work properly.