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临床工程师深圳市综普产品技术咨询有限公司深圳1-2万/月09-22

学历要求:本科|工作经验:3-4年|公司性质:民营公司|公司规模:

工作职责:1. 负责实施临床研究项目,实现内外部资源的调配,在经理的指导下完成试验项目的全面启动、执行和结束工作;2. 负责与项目客户、临床试验机构保持良好沟通,维护良好的合作关系;3. 解决协调员,监察员日常工作中的问题,确保临床项目顺利进行;4. 收集临床政策及临床中心动态,解读和传达有效临床信息给项目经理,为公司决策提供建议;5. 完成上级领导交办的其他工作。岗位要求:1. 本科及以上学历,生物/医学/临床/统计等相关专业;2. 熟悉医疗器械临床研究的相关法规,全面掌握临床试验管理规范的知识;3. 对医疗器械临床研究的各阶段工作完全了解。有成功临床实施案例;4. 具有2年以上CRO/医疗器械企业临床试验经验;5. 工作积极主动,良好的沟通协调能力和执行能力。

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法规/体系工程师(医疗器械)微珂医药技术服务(上海)有限公司上海-静安区2-3.2万/月09-22

学历要求:硕士|工作经验:3-4年|公司性质:民营公司|公司规模:50-150人

工作职责/任务:1. 负责公司所承接的医疗器械产品国内NMPA注册咨询、或欧盟CE认证咨询、或美国FDA注册咨询、体系GMP / ISO 辅导等工作;2. 负责撰写医疗器械注册资料、CE技术文档、NMPA注册文件、FDA-510k技术文档、风险管理、临床评价等注册资料编写;3. 接收和协助解决客户遇到的各类注册问题,有一定法规基础,具备一定的沟通表达能力,偶尔需要出差。4.负责对客户进行产品检测、过程确认、验证等事宜的辅导及培训;任职要求 :1. 医疗器械/医药/生物工程等医疗方面专业、从事医疗器械行业1年以上;2. 有第三方医疗器械注册、法规、认证从业经验者优先,有医疗器械注册或法规方面实习或从业经验者优先。3、有任何第三方技术服务从业经验者,熟悉CE,FDA,ISO 13485等法规者优先。4.良好的英语读写能力。

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注册专员长沙市健朗医疗科技有限公司长沙-岳麓区6-8千/月09-22

学历要求:大专|工作经验:1年|公司性质:民营公司|公司规模:少于50人

1.负责注册申报资料的文档签署及流程状态的跟踪;2.负责与产品注册关联的设计开发所需数据、资料的调研与整理;3.负责与产品注册申报相关的资料、文档的内部归档和外部对接;4.协助部门的日常行政事宜;5.负责相关产品注册的数据采集、整理、统计和分析工作;6.完成关于产品设计和产品描述的技术文档准备工作;7.负责产品申报的编写;8.具备良好的沟通力和理解能力。任职要求:1.医药、生物‘化学、高分子材料工程等相关专业本科以上学历,优秀应届毕业生即可,有1-2年工作经验者优先考虑;2.能够独立的完成文献的查找;3.有一定英语基础,能够查看国内外文献资料,了解医药相关标准;4.具有较强的发现问题、分析问题及解决问题的能力;

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医疗器械注册工程师北京劢迪可可医学技术有限公司北京-东城区0.6-1万/月09-22

学历要求:大专|工作经验:1年|公司性质:民营公司|公司规模:

职位描述:1.负责组织编写、修改产品的注册标准。2.负责样品整理并送检,做好检测工作中各方面协调工作。3.跟进检测结果,追踪检验报告交回公司商务部并登记存档。4.及时汇报检测过程中所出现的任何问题以及工作进度。职位要求:1.诚实,勤奋,高度的工作热情和创造力,具有良好的职业道德;2.大学专科以上学历,电子仪器,生物工程,化学工程等专业毕业,1年以上医疗行业工作经验;3.熟悉医疗器械标准,了解产品检测的流程,能独立编制产品标准;4.良好的沟通和协调能力;5.较强的独立工作能力及团队合作精神,较好的人际关系及高度的工作热情。

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法规工程师深圳华通威国际检验有限公司深圳1.2-2万/月09-22

学历要求:本科|工作经验:2年|公司性质:国企|公司规模:

岗位职责:1. 研究医疗器械(NMPA国内注册,欧盟CE MDR,FDA上市等)有关法律法规2. 为客户制定产品注册与产品上市流程与方案3. 协助客户准备产品注册与产品上市相关文件4. 协助客户完成产品认证并取得证书任职要求1. 医疗器械产品注册咨询行业2年及以上工作经验;2. 中级或以上职称;3. 工作适应能力强,具备时间管理概念4. 自我完善,自我驱动,具有良好的沟通能力及较强的团队协作精神5. 本科及以上学历,材料类,生物医学,分析化学或相关专业类专业6. 英语6级及以上或同等水平7. 个人能力优秀者(2,5,6条要求)条件可适当放宽工作时间:五天7.5小时工作制(08:30-11:45 13:00-17:15)工作地点:深圳市南山区科技园科技南十二路中国检验认证大厦福利待遇:试用期为员工购买五险一金为员工购买商业意外保险不定期为员工组织团体活动

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注册专员湖南灵康医疗科技有限公司长沙-岳麓区0.5-1万/月09-22

学历要求:大专|工作经验:1年|公司性质:民营公司|公司规模:50-150人

岗位职责:1、协助公司质量管理体系的构建与运行维护; 2、负责医疗器械产品的注册申报工作; 3、编写产品注册及质量体系相关文件与材料; 4、负责向相关机构递交材料,协调、跟踪、推进项目进展; 5、负责产品注册及质量体系相关材料的整理归档及保管工作; 6、及时汇总、分类、整理、归档相关部门出台的各项法规、文件、技术资料;7、领导安排的其他工作。任职资格:1、大专及以上学历,有1年以上医疗器械注册相关工作经验;2、熟练ISO13485在质量管理体系中的运用,熟悉医疗行业的法律法规;3、具备内审员资格或持有“医疗器械注册申报人员培训证书”者优先考虑;4、熟悉医疗器械产品注册及质量体系管理的法律法规和技术要求,具有良好的文字表达能力及扎实的文撰写功底,能够熟练撰写相关文件;5、熟悉医疗器械行业法规及注册认证流程;福利:五险、餐补、周末双休、带薪年假、节日福利、培训、团建以及完善的薪资晋升体系联系电话:0731-89704138

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研发体系专员武汉生之源生物科技股份有限公司武汉3.5-5千/月09-22

学历要求:本科|工作经验:无需经验|公司性质:民营公司|公司规模:150-500人

岗位职责:1.建立和完善公司研发体系,并编写相关的体系文件;  2.负责协助完成公司产品的注册工作;   3.及时收集体系运行的各种信息,定期向上级报告体系情况,满足公司工作计划;4.负责部门内部研发资料的审核及其他文件资料的提供;    5.跟踪验证内、外审、管理评审中发现的不合格情况,及时跟进整改工作; 6.负责对体系进行持续的改进,对存在的问题及时处理。  任职资格:1.医学、检验学、生物学、免疫学或药学等相关专业本科及以上学历;2.具有体外诊断试剂体系相关工作经验,熟悉医疗器械相关政策法律法规;3.掌握ISO13485体系,能对相关体系文件进行编写;4.具有较强的学习、沟通协调和文字处理能力。联系方式:邮箱:hr@szybio.com(请在邮件标题中注明应聘者姓名及岗位名称,同时以附件方式发送简历,对符合条件者我们会尽快给予答复。)办公电话: 027-87196282-816晋升通道:技术通道:技术员--研发助理工程师--研发工程师--高级研发工程师--首席科学家管理通道:管理预备队--研发主管--研发经理--研发总监工作时间:5天8小时工作制,周末双休,法定节假、婚、丧、产假通通有;工作环境:免费提供住宿、通勤车;薪资待遇:完整的薪酬体系,基本工资、奖金、各种补贴,年终奖,健全的调薪政策,让你保值更升值;社会保险:六险一金,含社保、公积金、补充商业险,让你成家立业有保障;健康体检:公司每年组织员工进行免费健康体检;人才培养:带薪岗前培训、入职培训、在岗培训,集团项目培训,OJT培训,还有机会外训;文化活动:年会、生日会、团建、聚餐、各种有趣的员工活动,国内外旅游、各种兴趣爱好协会,总有你喜欢的项目;精神家园:党总支、团总支、工会,落户、档案接收,这里也是你的精神家园。

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注册及质量专员莱谱光电科技(上海)有限公司上海-浦东新区8.5-9.5千/月09-22

学历要求:本科|工作经验:3-4年|公司性质:外资(欧美)|公司规模:50-150人

1. 从事国产三类有源医疗器械的注册申报工作,保证注册流程顺利进行并及时获取注册证;2. 按照相关的法律法规起草产品技术要求等注册文件,解决注册过程中遇到的困难和问题;3. 与政府部门联系和沟通,跟踪审批情况,与检验机构联系并保持良好关系,跟进检测进度;4. 负责协调各部门建立满足法规要求的GMP管理体系,负责GMP管理体系的实施、维护,并组织相关部门进行体系内审和评价。4. 参与公司质量体系建设、质量体系评审工作,负责本部门的质量改进工作。5. 参与本部门文件体系的检查、策划;参与相关文件的起草、修订;负责体系文件的执行6. 完成上级交代的其他任务要求能力1. 较强的口头表达能力和文字编辑能力;2. 具有良好的团队合作精神和人际沟通、组织协调能力;3. 能够熟练操作办公软件;4. 具备能够处理突发事件的能力。5. 英文要求,读写、听说良好。任职资格1. 医学,药学,电子,医疗器械等相关专业,本科以上学历2. 熟悉医疗器械法律法规,三年以上医疗器械RA或QA经验,有GMP体系和有源医疗器械相关经验的优先

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医疗器械注册专员陕西新时代生物转化检测有限公司西安-西咸新区6-8千/月09-22

学历要求:大专|工作经验:2年|公司性质:民营公司|公司规模:少于50人

岗位职责:1.熟悉医疗器械注册法规及项目开展流程;编写医疗器械产品技术要求,跟进注册检测并取得注册检测报告;2.编写、整理医疗器械产品注册申报资料;3.医疗器械产品注册批报、跟进、协调及取证等相关工作; 4.注册相关文件的整理和归档;5.与相关部门保持良好的联系,密切跟进注册法规的变化。 任职资格: 1.医药专业,大专及以上学历;

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CE认证专员上海昊海生物科技股份有限公司上海0.8-1.5万/月09-22

学历要求:本科|工作经验:1年|公司性质:民营公司|公司规模:

职责描述:1.      负责CE产品认证相关文件和资料的编写和翻译;2.      负责关注欧盟政府网站,及时获知欧盟CE认证法规的变化情况,向公司管理层汇报;3.      负责产品国外注册资料的编写和翻译工作,关注与产品海外注册相关国家政府网站,及时获知相关注册要求法规的变化,及时报备部门负责人; 4.      负责翻译与CE产品认证、产品海外注册相关法规、EN标准、ISO标准、欧洲药典、美国药典等英文资料;5.      完成上级交办的其他工作任务。  任职要求:1.      本科学历,英语、生物、化学及药学相关专业,英语专业八级;2.      熟悉无源、植入型三类医疗器械产品注册流程,接受过ISO13485质量体系等知识培训者;或者熟悉医疗器械CE认证流程,能够编写相关认证技术文档,可优先考虑; 3.      逻辑思维能力优秀,责任心强,能吃苦耐劳,具有团队合作精神,熟练使用电脑办公软件,良好的学习能力,身体健康,服从工作安排。

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001临床CRA江苏关怀医疗器械有限公司苏州0.6-1万/月09-22

学历要求:本科|工作经验:2年|公司性质:事业单位|公司规模:

1、完成临床试验中心筛选、启动、日常监察及收尾工作,确保试验符合GCP要求和试验方案以及部门SOP开展;2、协调研究中心研究人员,培养并维系与研究者的良好关系;3、按项目监察计划和部门SOP完成监察并及时提交监查报告,及时反馈发现的问题,保证临床试验的质量和进度;4、配合QA经理的稽查工作,及时整改存在的问题;5、监督CRC的工作质量和进度。岗位要求:1、本科以上学历,临床医学、药学相关专业,英语4级以上2、有1-3年医疗器械或药物临床试验经验,熟悉肾内科项目的优先3、沟通能看良好、书面写作能力良好;具有网络检索能力和学术数据检索能力;熟悉GCP法规

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医疗器械注册专员(宁波)宁波龙泰医疗科技有限公司宁波6-8千/月09-22

学历要求:大专|工作经验:2年|公司性质:民营公司|公司规模:

岗位职责:1、负责新产品的注册、生产许可证生请、注册证变更和延续注册;2、负责医疗器械法律法规和相关标准的收集和动态跟踪;3、负责产品注册检测的送检和沟通协调;4、负责产品临床评价工作;5、负责产品注册资料的整理和汇编。任职要求:1. 医疗/生物医学工程/机械等理工科相关专业,本科及以上学历;2. 有2年以上医疗器械产品注册经验,熟悉第二类和第三类医疗器械注册流程,具有有源医疗器械产品注册经验者优先;3. 具有较好的思维逻辑及文案编辑能力;4. 具有良好的沟通技巧和协调能力;5. 富有团队合作精神,具有一定的项目团队管理能力。

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医疗器械注册总监杭州莱普晟医疗科技有限公司杭州1.5-2万/月09-22

学历要求:本科|工作经验:3-4年|公司性质:民营公司|公司规模:

岗位职责: 1、负责公司医疗器械产品在国内的注册事宜;2、按照相关法律法规及标准的要求,起草产品标准,跟进产品检测,注册检验,临床试验等; 3、协助编写、管理公司产品的技术文档,协助制定临床研究方案,并协调相关资源进行临床试验研究; 4、与国家药监局等部门联系沟通,确保各个注册申请的报送、审评和审批的顺利进行,实时跟踪产品注册进程,确保按时获证; 5、与检验、测试、认证机构保持密切联系,建立良好关系,接待陪同审核员开展相关工作,确保产品的注册检验和质量标准复核的顺利进行; 6、了解并研究国内国际新产品认证注册的法律法规,为新产品注册或认证策略提供咨询建议。任职要求: 1、 生物、化学、制药、医学等相关专业本科以上学历;2、 熟悉医疗器械注册流程,完成产品注册标准的编写、注册文件准备、联系产品检测等事务;有3年以上医疗器械产品注册工作经验,并成功注册产品,三类医疗器械经验者优先; 3、 熟悉国家有关医疗器械的各项法律、法规及国家和行业标准4、 熟悉质量管理体系,医疗器械生产质量管理规范等法规标准,具有ISO13485内审员证书。5、 具有良好的沟通能力与协调能力; 6、 工作细致、严谨、主动、条理性强,有高度的责任感和良好的团队合作精神。

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医疗器械注册郑州品正科技有限公司郑州-中原区6-8千/月09-22

学历要求:大专|工作经验:1年|公司性质:民营公司|公司规模:150-500人

岗位职责:1、负责有关医疗器械的注册申报工作; 2、负责产品注册资料的收集、整理、编写等工作; 3、负责撰写产品的技术要求,熟悉产品注册检验的部门和流程; 4、负责医疗器械产品临床试验的开展,向相关政府部门递交注册资料; 5、安排产品的注册计划,跟踪注册进程,包括准备文件、产品检验、临床试验、体系审核等; 6、负责了解医疗器械注册方面的最新政策动态,更新公司内部的法规标准。 任职要求: 1、大专及以上学历,医疗器械、生物医学工程、检验、机械、电子、光学、医药等相关专业;2、熟悉产品注册、检验、临床审核流程者优先; 3、熟悉ISO13485 idt YY/T0287质量体系者优先;4、工作积极主动,具有良好的综合素质、较强的沟通协调能力;5、工作经验不限。双休;社保上班地址:郑州市电厂路大学科技园16号B座1702联系电话:0371-55677886

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医疗器械注册专员河南天森医疗器材有限公司海口3-5千/月09-22

学历要求:大专|工作经验:1年|公司性质:民营公司|公司规模:少于50人

岗位职责: 1、了解医疗器械申报流程,负责公司的医疗器械注册工作; 2、对注册项目进行分析评估并制订注册策略; 3、负责注册标准撰写和产品检测,注册申报资料的撰写提交和进度跟踪,按计划取得注册证; 4、与客户及药监部门建立并维护良好的工作关系。 任职要求: 1、有1年以上医疗器械产品注册工作经验,并成功注册产品; 2、熟悉国家有关医疗器械的各项法律、法规及国家和行业标准; 3、具有良好的沟通能力与协调能力; 4、能熟练应用电脑软件,进行办公自动化操作; 5、工作细致、严谨,有高度的责任感和良好的团队合作精神

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R3590393 RA LeaderGE医疗集团北京09-22

学历要求:本科|工作经验:5-7年|公司性质:外资(欧美)|公司规模:5000-10000人

Job Description SummaryYou provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Roles and Responsibilities1. GEHC ONLY - Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.2. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.3. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.4. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.5. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.Required Qualifications1. For roles outside of the USA- This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).2. For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).Desired CharacteristicsStrong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Note:To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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RA specialist (伴随诊断)安捷伦科技有限公司Agilent Technologies Co., Ltd.北京-朝阳区20-30万/年09-22

学历要求:本科|工作经验:无需经验|公司性质:外资(欧美)|公司规模:500-1000人

This position will be part of the Companion Diagnostics Regulatory Affairs team, reporting directly to the Companion Diagnostics regulatory affairs manager in China. This person will provide both strategic and operational support to ensure proper regulatory submissions, registrations, licenses and approvals in China. We are looking for a highly motivated and experienced Regulatory Affairs professional to join our Agilent team working within the Companion Diagnostics business. The role will work as individual contributor and be based in Agilent Beijing Campus. The person will also need to work efficiently with global R&D, manufacturing and other functions such as local commercial division. The preferred candidate would have experience in IVD and be familiar with Companion Diagnostics, and interactions with CNDA. The candidate must have good oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities *Plan, provide regulatory guidance, coordinate and manage the day-to-day CNDA pre-market approval submissions for Companion Diagnostics (CDx) and obtain approval of premarket product registration timely. *Inform other business units about changing regulations in IVDs and Companion diagnostics in China. *Interact with CNDA on registration requirements and monitor changes to requirements. *Independently manages and provide regulatory guidance to short-term and long-term projects. *Works directly with pharma companies in China. Internal Qualifications: * University degree or above in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred) *A minimum of 3 years of RA experience in IVD or medical device field. *Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics *Experience working directly with CNDA *Strong decision-making skills *Experience working in projects as part of project teams *Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements. *Knowledge of pathology and oncology is preferred * Personal competencies *Advanced skills in English both written and spoken *Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members. This position will be part of the Companion Diagnostics Regulatory Affairs team, reporting directly to the Companion Diagnostics regulatory affairs manager in China. This person will provide both strategic and operational support to ensure proper regulatory submissions, registrations, licenses and approvals in China. We are looking for a highly motivated and experienced Regulatory Affairs professional to join our Agilent team working within the Companion Diagnostics business. The role will work as individual contributor and be based in Agilent Beijing Campus. The person will also need to work efficiently with global R&D, manufacturing and other functions such as local commercial division. The preferred candidate would have experience in IVD and be familiar with Companion Diagnostics, and interactions with CNDA. The candidate must have good oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities *Plan, provide regulatory guidance, coordinate and manage the day-to-day CNDA pre-market approval submissions for Companion Diagnostics (CDx) and obtain approval of premarket product registration timely. *Inform other business units about changing regulations in IVDs and Companion diagnostics in China. *Interact with CNDA on registration requirements and monitor changes to requirements. *Independently manages and provide regulatory guidance to short-term and long-term projects. *Works directly with pharma companies in China. Internal Qualifications: * University degree or above in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred) *A minimum of 3 years of RA experience in IVD or medical device field. *Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics *Experience working directly with CNDA *Strong decision-making skills *Experience working in projects as part of project teams *Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements. *Knowledge of pathology and oncology is preferred * Personal competencies *Advanced skills in English both written and spoken *Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members.Requirements:* University degree or above in a technical discipline (bioengineering,  chemical, biology, laboratory diagnosis, pharmaceutical preferred)*A minimum of 3 years of RA experience in IVD or medical device field.*Strong skills in regulatory strategy and planning, preferably with in vitro diagnostics*Experience working directly with CNDA*Strong decision-making skills*Experience working in projects as part of project teams  *Capability of working in multiple project teams in parallel and a  sense-of-urgency in meeting deliverables and project requirements.  *Knowledge of pathology and oncology is preferred*Personal competencies*Advanced skills in English both written and spoken*Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and countries, particularly with regulators and standard committee members.

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Regulatory Affairs Manager飞利浦(中国)投资有限公司 Philips (China) Investment Co.,Ltd.苏州-工业园区2.5-3万/月09-22

学历要求:本科|工作经验:8-9年|公司性质:外资(欧美)|公司规模:10000人以上

In this role, you have the opportunity to   Be a part of team of build a high growth business that will help improve the lives of millions of ***, while advancing Philips digital transformation journey as a global leader in Health Technology.   You are responsible for   Lead the regulatory tasks/assignments to support PD China biz growth.Actively participate as team member on all assigned new products. Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions. Create and file submissions; Communicate with authorities regarding these submissions. Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products. Review changes in existing products to determine need for new/revised submissions or document reason for no submission.Facilitate testing and inspection from CFDA, ETL, CSA, TUV and other regulatory agencies.   You are a part of   A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the Marketing Director.   To succeed in this role, you should have the following skills and experience   Bachelor’s Degree & minimum of 8 years’ experience in the medical device industry or with medical product regulatory agencies. Experience of Class III active medical device registration with NMPA is strongly preferred.Ability to prioritize, plan & evaluate deliverables to established strategic goals.Proven application of analytical skills in a regulatory environment.Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.Demonstrated knowledge & experience conducting scientific, regulatory or business research.Strong problem solving and negotiation skills.Ability to work well independently & in a team setting.Knowledge of Quality Management Systems (QMS).Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.    In return, we offer you   We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.     Why should you join Philips?   Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.   To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions

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注册专员/Regulatory Specialist上海罗氏制药有限公司上海总部北京1-1.5万/月09-22

学历要求:本科|工作经验:2年|公司性质:合资|公司规模:1000-5000人

You will be responsible for filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP mannerMain Tasks & ResponsibilitiesPrepare the registration dossier to submit to NMPA and obtain the approval to meet the registration plan.Make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, share points, V drive, and notify all the stakeholders per company SOP requirements.Complete the related payment procedure in systems on time, place order for FOC for the QC testing.Working together with RAM, active join the discussion and verification of in the national standard or panel verification or national /industrial standard discussion and verification.Working together with global team, to draft the PTR and complete the type testing on time if needed.As a member of RD, provide active and strong regulatory supports to internal dep. as needed.Initiatively deal with daily works. Keep records. Have clear filing and maintain of all documents, update in RA related IT systems, share points, V drive on time.Other projects or tasks assigned by line manager.Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.Basic Requirements of the JobYou should have not less than 2 years’ experience in medical regulatory affairs, focusing on testing center and clinical trial, and understand IVD products’ standard like industry and national standards (YY and GB)You should have high enthusiasm and devotion, work hard and earnestYou should be willing to work under pressure, self-starting and self-inspiringYou should be honest and open, excellent interpersonal communication skill, ability of social activity and collaborationYou should be innovating with good independent working abilityYou should have energetic team spirit

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注册部负责人国瑞怡康医学检验所(上海)有限公司上海-青浦区80-100万/年09-22

学历要求:硕士|工作经验:5-7年|公司性质:民营公司|公司规模:少于50人

岗位职责: 1、依据公司战略发展规划,负责公司项目/产品的注册申报工作; 2、带领团队,负责IVD诊断试剂产品线注册管理和注册项目规划管理; 3、主管公司二类、三类产品线注册及生命周期计划制定和执行; 4、密切跟进注册项目进度,解决注册过程中的法规和注册问题; 5、负责协助IVD研发部门确认注册产品研究开发和验证满足法规的要求; 6、与各级药监单位建立保持良好的联系,维护注册相关主管部门和专家的资源体系,推进注册进展; 7、关注掌握行业相关法规、注册政策的最新动态,同时为新产品注册或认证策略提供咨询建议; 8、承担注册法规、政策的宣传任务,为公司相关部门/人员提供法规标准、政策信息的支持和培训。 任职要求: 1、硕士及以上学历,5年以上IVD注册工作经验,有三类产品注册成功经验者优先,熟悉免疫组织化学、PCR、NGS产品技术平台者优先,具备FDA、日本以及CE注册经验者优先; 2、熟悉二类、三类产品注册流程,熟悉体外产品的相关注册技术审查指导原则及相关标准,熟悉伴随诊断产品的注册和临床要求; 3、良好的沟通表达、组织协调及谈判能力,适应性和抗压性较强; 4、具备出色的信息和文字处理能力; 5、具有较好的英语水平,能够独立查阅、翻译国外文献; 6、能够接受因工作需要的不定期出差。

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