Senior Regulatory Affairs Manager

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Straumann® stands for premium Swiss quality, precision, and innovation delivering confidence in dentistry, backed by the largest global scientific network. As the global leader in implantology, we deliver cutting-edge innovations that are regarded as industry benchmarks and disruptive technological breakthroughs, supported by long-term scientific evidence.

We push the boundaries to enable the next generation of dental care.

士卓曼代表着瑞士优异的质量、精度和创新，以全球强大的科研网路为支持，让人们对牙科充满信心。作为口腔美学解决方案的全球领先者，士卓曼在长期循证医学和科学研究的支持下，提供被视为行业标杆和颠覆性创新技术突破的尖端创新成果。我们不断突破界限，为口腔健康保驾护航。

Manufacturing and operations are at the centre of our business, ensuring the production of our products and equipment that meet the needs of our customers and their patients. A career in manufacturing and operations requires a unique combination of technical expertise, attention to detail, and the ability to work collaboratively with a variety of different people.

制造和运营是我们业务的核心，确保我们的产品和设备的生产能够满足客户及其患者的需求。制造和运营的职业需要技术专长、对细节的关注以及与各种不同人员协作的能力的独特组合。

Position Summary职位概述

Oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Keeping track of the ever-changing legislation in all the regions in which SMCN wishes to distribute its products. Advising on legal and scientific restraints and requirements. Collecting, collating and evaluating scientific data. Provides advice and support to the Design team during the conceptual and development phase, ensures the compliance of all products cleared with applicable regulatory requirements. Oversee Post Market activities and reporting to authority as applicable in case of adverse event. Manages RA manager and PMS team.

这个职位监督所有监管事项并制定总体战略，确保组织遵守适用的法规。开发流程和系统，确保处理和监控所有必要的许可、备案、认证和许可证。就法律和技术方面的限制和要求提供建议。收集、整理和评估数据。在概念和开发阶段为设计团队提供建议和支持，确保所有通过审核的产品符合适用的监管要求。监督上市后活动，并在出现不良事件时向有关部门报告。管理 RA 经理和 PMS 团队。

This position is based in our Shanghai Campus and reports directly to Head of QARA Shanghai campus.

该职位在上海工厂工作，直接向上海工厂质量和法规负责人汇报。

Major Responsibilities of the Position: 主要岗位职责

This position is responsible for, but not limited to, the following: 该职位负责但不限于以下工作：

• Liaison with Regulatory Bodies and Authorities to demonstrate safety and effectiveness/performance of SMCN products in order to efficiently gain market clearance;
• 与监管机构和当局联络，以证明 SMCN 产品的安全性和有效性/性能，从而有效地获得市场许可；
• Ensure that all products distributed by SMCN are meeting applicable regulatory requirements
• 确保 SMCN 分销的所有产品符合适用的监管要求；
• Guide and coach stakeholders in Regulatory and Compliance topics with particular focus on product safety and effectiveness/performance;
• 指导和辅导利益相关者了解监管和合规主题，尤其关注产品的安全性和有效性/性能；
• Guide and supervise RA Manager and coordinate their daily activities
• 指导和监督 RA 经理并协调其日常活动；
• Liaise with the Quality Head of SMCN to maintain compliance
• 与 SMCN 质量负责人联络，以保持合规性；
• Provide adequate resources including technical support to project teams to assure that all SMCN products are designed, manufactured and distributed in such a way that they are safe and effective for their intended use;
• 为项目团队提供充足的资源（包括技术支持），以确保所有 SMCN 产品的设计、制造和分销符合其预期用途的安全和有效性；
• Ensure competency and continuous education of the RA&QA teams for regulatory and compliance;
• 确保 RA&QA 团队在监管和合规方面的能力和持续教育；
• Ensure regulatory submission planning accuracy
• 确保法规提交规划的准确性；
• Support the Regulatory Affairs teams in Straumann Group and at subsidiaries/distributors in preparation of local submissions, when applicable;
• 在适用的情况下，支持 Straumann 集团和子公司/经销商的法规事务团队准备当地申报材料；
• Supervise the process of establishing project-related RA strategies and follow up on execution during the projects;
• 监督项目相关 RA 战略的制定过程，并跟进项目期间的执行情况；
• Assure that the Technical Documentation complies with appropriate regulations;
• 确保技术文档符合相关规定；
• Supervise creation and maintenance of Regulatory Technical Files;
• 监督监管技术档案的创建和维护；
• Supervise the assessment of potential risks and the classification of the medical device in accordance with applicable regulations;
• 监督潜在风险评估，并根据适用法规对医疗器械进行分类；
• Support/review/approve labeling (labels, IFUs, marketing material) from a regulatory point of view;
• 从监管角度支持/审查/批准标签（标签、IFU、营销材料）；
• Support audits and inspections of Notified Bodies and Regulatory Agencies;
• 支持指定机构和监管机构的审计和检查；
• Support/assess change requests in accordance with MDR and further regulatory requirements;
• 根据 MDR 和其他监管要求，支持/评估变更请求；
• Interact with authorities, Notified Bodies and other approving authorities;
• 与主管部门、指定机构和其他审批机构互动；
• Ensure Post Market activities are well established and maintained.
• 确保建立和维护良好的市场后活动；
• Review and support PMS trend analysis for further decision where applicable
• 审查和支持项目管理系统趋势分析，以便在适用情况下做出进一步决定；
• Ensure reporting to authority when applicable is done on time and with accuracy.
• 确保按时、准确地向主管部门提交报告；
• The role will have full responsibility for the coordination, monitoring and reporting of regulatory projects related to new products, line extensions, life cycle products.
• 该职位将全面负责与新产品、产品线扩展、生命周期产品相关的监管项目的协调、监督和报告；
• This role will get complete visibility for project development and monitors RA planning adherence including the management and communication of changes, will ensure a communication on a regular basis the progress of the registration projects, will ensure that internal processes and metrics are aligned to create highest visibility within SMCN and the corresponding commercial regions
• 该职位将获得项目开发的全面可见性，并监测 RA 计划的遵守情况，包括变更的管理和沟通，将确保定期沟通注册项目的进展情况，将确保内部流程和指标保持一致，以便在 SMCN 和相应的商业区域内创造最高的可见性；
• Will assure the implementation and compliance to applicable regulations for Straumann group, design centers and manufacturing sites.
• 将确保 Straumann 集团、设计中心和生产基地执行和遵守适用法规；
• Will act Product Safety Officer (PSO) and support Safety Board where applicable to ensure timeliness of actions
• 将担任产品安全官（PSO），并在适用情况下为安全委员会提供支持，以确保行动的及时性；
• Other duties been assigned by manager
• 经理指派的其他职责。

Qualifications:

• Bachelors degree or Masters degree preferred
• 学士学位或硕士学位优先考虑。
• Must have 10+ years RA experience in medical device manufacturing field with focus on Class II and Class III medical devices.
• 必须在医疗器械制造领域拥有 10 年以上的 RA 经验，重点是二类和三类医疗器械。
• Must have direct experience with NMPA. Experience with other global regulatory authorities is a plus.
• 必须具有 NMPA 的直接经验。有其他全球监管机构工作经验者优先。
• Experience with overseas registration
• 具有海外注册经验。
• Must have strong verbal and written English skills. Experience working with global teams is preferred
• 必须具备较强的英语口头和书面表达能力。有与全球团队合作经验者优先。

What can you expect from us? 我们能为你提供什么？

• An agile and ambitious environment: We are #ChangeMakers.
• Open, friendly colleagues who #collaborate and #support each other: We are #Players+Learners.
• The #freedom to #create and #engage: You can leave your #FootprintInDentistry.
• An employer who invests in our #inspiring corporate #culture.
• The #opportunity to develop yourself as a person and in your #career. We #grow.
• #Attractive workplaces at great locations - We are a #GlobalPlayer.
• A good salary and many other cool #benefits (depending on location).
• 灵活而雄心勃勃的环境：我们是#变革者。
• 开放、友好的同事#相互协作和#相互支持：我们是#玩家+学习者。
• #创造和#参与的#自由：你可以在#牙科行业留下你的足迹。
• 投资于“鼓舞人心的企业”文化的雇主。
• 在#职业生涯中发展自己的#机会。我们#成长。
• #位置优越、极具吸引力的工作场所——我们是一个#全球玩家。
• 高薪和其他诸多优越#福利（取决于工作地点）。

About Straumann

The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.

Headquartered in Basel, Switzerland, the Group currently employs more than 7300 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners.

For more information, please visit: Straumann Group

Information :

• Company : Straumann Group
• Position : Senior Regulatory Affairs Manager
• Location : 上海市
• Country : CN

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