[上海]上海博进医疗器械有限公司

职位：法规注册管培生
发布时间：2025-02-18
工作地点：上海
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
专业1:生物医学
专业2:临床医学（医学）
职能类别:医疗器械注册
年收入：12-15万
一、岗位职责
1.文件编审：负责从合规性上编写并审核产品技术要求等相关注册文件；
2.资料准备：负责确认检测机构所需的送检资料、样品和其他物品，负责产品注册申报工作管理，收集、准备产品注册所需技术文件和申报材料，确保文件材料完整、准确；
3.注册跟踪：编写并提交注册申请，跟踪注册进度，联络沟通认证机构，及时处理审核过程中的问题，确保产品注册顺利完成；
4.验证协助：协助医疗器械注册过程中的设计验证事项，如生物相容性试验、灭菌消毒验证试验、有效期验证试验、包装验证试验等，从合规性上协助编制或审核试验方案，负责送检及与检测机构的沟通协调，协助解决检测过程中出现的问题，直至检测合格;
5.合规性审查：根据相关法规对流程文件等进行合规性审查的正确性，确保团队遵从各项流程规范和标准。参与公司内部及外部审核、认证工作，并针对审核发现进行过程监督及效果验证。
二、任职要求
1.2024-2025届本科及以上学历，医疗器械相关专业（电气、生物医学类、电子信息软件类、临床医学、机电一体化、生物医学工程）优先；
2.对医疗器械注册法律法规（如注册备案管理办法、监督管理条例、注册体系核查指南）和ISO13485质量管理体系有了解的优先；
3.对欧盟（MDR）CE认证、美国FDA认证、MDSAP五国认证相关法规及要求有了解者优先考虑；
4.逻辑清晰，具有较强的文字编写能力，具有较强的组织、协调和沟通能力，责任心强，具备团队合作精神；
5.脚踏实地，愿从基层做起，积累经验，逐步晋升为部门负责人，责任心强，确保项目落实并持续监督；
6.沟通能力强，善于跨部门合作，能用通俗语言表达专业术语，简洁总结复杂事物；
7.皮实、不玻璃心，坚持原则，积极解决冲突，面对困难心态稳定，主动寻找解决方案。 公司简要介绍：
公司名称:上海博进医疗器械有限公司
公司类型:民营公司
公司规模:150-500人
公司介绍:上海博进医疗器械有限公司（以下简称“博进”）是中国骨科领域领先的集研发、生产、销售于一体的医疗器械知名企业，同时也是业界相关解决方案的提供者。博进主要业务集中在医用电动工具、手提式X射线***、骨折治疗仪、骨科手术相关附件以及康复等五大领域。博进以“关注病患及医护需求，创新研发高科技骨科产品”为使命，致力于将企业打造成守护人类骨科健康的保障平台。

博进成立于1992年，总部设在中国上海，并在北美、欧洲、亚洲等120多个国家和地区设有销售公司或团队，员工近300名，形成了国内外的营销和服务网络，为客户提供专业高效的服务。目前，博进的产品已广泛应用于全球120多个国家，中国2万多家医疗机构、95%以上的三甲医院。

生命诚可贵、健康价更高。博进始终秉承以拯救病患为己任，以降低医疗成本为宗旨，依托新科技、新理念将高品质的骨科产品为社会大众提供健康保障。博进的发展历程是坚持进取的历程，为解决各类疑难杂症，博进不断在全球收集骨科临床案例和需求，通过对产品和技术的不断迭代，攻克了业内各类技术难题，成为业界标杆企业。

博进在注重核心技术和开发高品质科技产品的同时，也尊重人才、注重人才梯队的建设和发展。博进的研发团队已占员工总数的20％，高素质的人才队伍，保证了博进坚持为全球客户提供稳定、新颖骨科器械及综合服务的实力。公司发展的每个阶段，也是公司高层和管理团队管理理念不断进步与完善的过程，可以看到博进人坚韧不拔、精益求精的创业激情与精神，公司迈出的每一步，都在持续地推动企业的健康发展，全体员工对公司稳步发展充满信心，也为能成为博进人而感到自豪。

博进纪实
1992年 博进公司成立
1993年 与第二军医大学合作并成立产品制造基地
1994年 首代超低剂量手提式X射线***问世
1995年 首台骨折治疗仪诞生
1996年 第二生产基地在上海大学开始运作
1997年 销售业绩跃居国内本行业前列，研发投入明显增加
1998年 BJ1000系列骨科动力产品问世，成为国内研发成功此类产品的企业
2000年 CCD成像自带供电系统的BJI-IJ型超低剂量手提式X射线***研发成功，填补了国内此项领域的空白
2001年 BJ 4000型骨科系列产品研发成功
2002年 BJ 6000型骨科系列产品研发成功
2003年 BJ 8000型骨科系列产品研发成功
2005年 成为中国骨科动力产品和X射线***的研发、生产、销售企业
2009年 嘉定制造基地项目完工并开始生产
2010年 BJ4300与 BJ5000型骨科系列产品发布并投放市场
2011年 医用电动锯钻荣获“上海医疗器械名优产品”称号
目前博进公司已经拥有八大系列、多达100多种不同类型的骨科用产品，先后通过了“3C”、“ISO9000”、“ISO13485”、“欧盟CE”、“FDA注册号3008787426”等一系列质量管理认证。

随着公司经营规模的不断增长，目前正招募“激情、创新、进取、韧力”的各类专业人才加盟。博进不但为员工提供专业的工作环境，还为员工提供了大量职业发展机会及上升通道，博进欢迎有志之士的加入，共同为中国医疗事业贡献绵薄之力！

Bojin is one of the Chinese leading manufacturers and solution providers of orthopedic medical devices. The business is mainly focused on:
?Surgical Power Tools
?Portable X-ray Fluoroscopy
?Orthopedic Treatment Instruments
?Other orthopedic surgery-related accessories and rehabilitation products.

Firmly committed to our mission of “developing high-tech orthopedic products with continual innovation whilst attaching importance to patients and health care needs”, we are dedicated to build this company as a platform to ensure human health in the field of orthopedics.
Bojin was founded in 1992 and headquartered in Shanghai, China. Its sales companies or teams are present in more than 120 countries, including North America, Europe, and Asia. Nearly 300 employees structure marketing and service networks at home and abroad, providing customers with professional and efficient services. Today, Bojin products have been widely used in more than 120 countries, over than 20,000 medical institutions in China, and more than 95% of the ***-class hospitals.
Life is precious and health is more expensive. Bojin always believes saving patients as its mission, reducing medical costs as its purpose, relying on new technology and new ideas to provide high-quality orthopedic products. The development process of Bojin is the process of keeping forging ahead, it has been collecting clinical cases and needs of orthopedics all over the world. Through continuous iteration of products and technologies, Bojin has overcome all kinds of technical problems in the industry and become a benchmark enterprise in the industry.
While focusing on core technologies and developing high-quality technology products, Bojin also respects talents and focuses on the construction and development of talent teams. Bojin’s commitment to research and development has accounted for 20% of the total number of employees, and a pool of highly talented team members has guaranteed Bojin's strength in providing stable and innovative orthopedic equipment and comprehensive services to customers worldwide. Each stage of the company's development is also a process of continuous improvement of the management philosophy. It can be seen as Bojin's entrepreneurial passion and spirit of perseverance and excellence: promoting healthy development of the company. All employees are full of confidence in the company's steady development and are proud of being an employee of Bojin.

Milestones:
?1992, founded in Shanghai, China
?1993, established the manufacturing base by cooperating with Second Military Medical University
?1994, the *** generation ultra-low-dose portable X-ray Fluoroscopy was developed
?1995, the *** orthopedic treatment instrument came into the world
?1996, the second production base started operations at Shanghai University
?1997, achieved the highest annual sales in the domestic markets and R & D investment was increased significantly
?1998, BJ1000 series of orthopedics power products was released, becoming the *** domestic company to successfully develop such products.
?2000, CCD imaging with power supply system, BJI-IJ, a low dose of portable X ray fluoroscopy developed firstly in China, which filled the gap in this field in China
?2001, BJ4000 series of orthopedics power products was launched
?2002, BJ6000 series of orthopedics power products was offered to the market
?2003, BJ8000 series of orthopedics power products was developed
?2005, became the *** and largest Chinese research and development, production and sales enterprise of orthopedics power products and X ray fluoroscopy
?2009, Jiading manufacturing base project completed and began production
?2010, BJ4300 and BJ5000 series of orthopedics power products were launched.
?2011, Medical electrical drill and saw won the title of "Shanghai famous and excellent medical equipment product

At present, Bojin has 8 series and more than 100 different types of products which have been widely used in orthopedics. 3C, ISO9000, ISO13485, CE mark and FDA approval have been awarded one after another.

As the company business scale continues to grow, it is currently recruiting all kinds of professionals who are "passionate, innovative, with a entrepreneurial mindset, and brave" to join. Bojin not only provides employees with a professional working environment, but also provides them with a wide number of career development opportunities.

We welcome ambitious people to join and contribute to the China’s medical career development.