滚动信息：R&A Manager
[1065630]
招聘单位：欧德利希医疗科技（太仓）有限公司
发布：[2025-07-14]
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职位信息 |
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| 职位名称： | R&A Manager | 月薪水平： | 15000-25000 |
| 工作性质： | 全职 | 职位类别： | 经营管理类:部门经理 |
| 工作地区： | 太仓城厢 | 作息制度： | 双休 |
| 食宿情况： | [午餐] | 招聘人数： | 1人（当前应聘11人） |
| 福利待遇： | [五险一金] [带薪年假] [节假日福利] [绩效奖金] [定期体检] | ||
| 工作描述： |
1. Prepare, generate and review the dossiers (include but not limited to CMC & Nonclinical & Clinical module) of Company’s products’ IND/NDA submission package; keep tracking the product registration process, response of evaluation comments from authority; handle the review issues timely with colleagues. 2. Execute the All life -cycle regulation affairs management of Company’s products. 3. Formulate the plan for domestic and international product registration strategies and tasks for review and approval. 4. Search and follow up and the regulations & guideline & tech documents which from domestic and overseas, provide policy support for company products’ submission dossiers. 5. Obtain the support of government affairs team of uUlm to maintain close communication with relevant medical device regulatory agencies and support regulatory affairs. |
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应聘要求 |
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| 学历要求： | 本科 | 专业类别： | [机械/仪表类] [管理类] [材料类] |
| 详细专业要求： | 不限 | ||
| 适宜性别： | 不限 | 年龄要求： | 不限 |
| 工作经验： | 6年 | 户籍要求： | 不限 |
| 外语能力： | 英语 熟练 | 计算机能力： | 熟练 |
| 技能资质： | 不限 | ||
| 其它要求： |
1.BS degree or above in a science-related discipline with above 6 years of regulatory experience in medical device company. 2.Comprehensive regulatory knowledge and understanding of medical device product development. 3. Familiar with the process and requirements for domestic and international registration and approval of medical devices, proficient in operating related businesses 4. Demonstrated experience in contributing to the preparation of regulatory submissions of the medical device products. 5. Excellent written and verbal communication skills and proficiency in English. 6. Proven leadership and project management skills, with the ability to work both as a team member and independently. |
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| 首次录入时间： | 2025-06-23 15:19:59 | ||
