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Open nowPosted 6 days ago

医疗器械注册工程师-深圳

anker-in/campushirecn495 open roles

Where
Shenzhen, Guangdong, Chinese Mainland
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Your applicationOpen now医疗器械注册工程师-深圳anker-in/campushirecn · Shenzhen, Guangdong, Chinese Mainland

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  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. anker-in/campushirecn postings stay open a median of 1 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 6 days ago

anker-in/campushirecn median: 1 days open

The posting

你将参与： 1.协助注册申报：在导师/团队指导下，参与有源医疗器械及医疗器械软件产品在 NMPA（二类/三类）及海外市场（CE / FDA）的注册申报，协助制定注册计划并跟进执行。 2.注册资料整理与撰写：负责撰写、整理、校对注册申报资料，包括产品技术要求、说明书、软件研究资料、检测报告等。 3.检测与申报跟进：对接第三方检测机构，跟进 GB 9706.1、YY 9706.102（EMC）及软件相关检测进度，整理审评补正材料。 4.法规资料收集：跟踪并收集整理国内外医疗器械法规、标准、指导原则，形成资料库支撑团队合规评估。 5.文档与流程支持：负责注册变更、延续注册等日常事务，做好文档归档与流程配合。 6.成长培养：接受系统化带教与轮岗，逐步成长为可独立负责注册项目的工程师。

1. 2027届毕业生，本科及以上学历，生物医学工程、临床医学、电子、自动化、计算机、软件、医疗器械等相关专业。 2.有医疗器械注册、法规事务、质量体系或检测相关实习/项目/课程/竞赛经历者优先。 3.了解或学习过《医疗器械监督管理条例》、ISO 13485、GB 9706 系列等法规标准者优先。 4.具备扎实的文档撰写能力、逻辑性与学习能力，做事细致、耐心。 5.英语读写能力良好，能阅读英文法规/标准（CET-6 或同等水平者优先）。 6.责任心强、沟通协作良好，愿意在医疗器械法规注册领域长期发展。 加分项 在校期间获得奖学金（国家奖学金、校级及以上奖学金者优先）。 有注册申报、临床评价、网络安全或软件法规相关实习/项目经历。 熟悉有源器械或医疗软件产品，参与过相关课程/竞赛/毕设项目。

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