R&A Manager
[1065630]
招聘單位：歐德利希醫(yī)療科技（太倉）有限公司
發(fā)布：[2025-07-21]
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職位信息 |
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| 職位名稱： | R&A Manager | 月薪水平： | 15000-25000 |
| 工作性質(zhì)： | 全職 | 職位類別： | 經(jīng)營管理類:部門經(jīng)理 |
| 工作地區(qū)： | 太倉城廂 | 作息制度： | 雙休 |
| 食宿情況： | [午餐] | 招聘人數(shù)： | 1人（當(dāng)前應(yīng)聘12人） |
| 福利待遇： | [五險一金] [帶薪年假] [節(jié)假日福利] [績效獎金] [定期體檢] | ||
| 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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應(yīng)聘要求 |
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| 學(xué)歷要求： | 本科 | 專業(yè)類別： | [機械/儀表類] [管理類] [材料類] |
| 詳細專業(yè)要求： | 不限 | ||
| 適宜性別： | 不限 | 年齡要求： | 不限 |
| 工作經(jīng)驗： | 6年 | 戶籍要求： | 不限 |
| 外語能力： | 英語 熟練 | 計算機能力： | 熟練 |
| 技能資質(zhì)： | 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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更多職位信息 |
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| 首次錄入時間： | 2025-06-23 15:19:59 | ||
