Senior Regulatory Affairs specialist/associate Manager-Suzhou,China

Dentsply Sirona; Vancouver; On-site; CAD 59,000 - 99,000; Full time

Job summary

一家国际牙科产品制造商正在寻找一位经验丰富的高级法规事务经理，负责确保产品注册符合政策和法律要求。理想的候选人需具备至少10年的法规事务经验，能够独立管理复杂项目。在快速发展的行业中，您将与领导团队一起推动创新，提升全球口腔健康。

Benefits

迅速的职业发展

高绩效的企业文化

Qualifications

• 至少10年注册经验，至少6年设备和软件监管事务工作经验。
• 独立完成复杂的产品变更和新产品注册的经验。
• 熟悉医疗器械法规和设备、软件注册流程的要求。

Responsibilities

• 建立和实施注册策略以获得产品批准。
• 汇总注册申请文件并及时提交。
• 与NMPA或当地药监局沟通注册要求并跟踪变化。

Skills

高诚信度

良好的沟通能力

细节导向

学习能力强

对任务的紧迫感

Education

本科及以上学历，设备，电子，计算机相关专业

Job description

登士柏西诺德是全球最大的专业牙科产品和技术制造商，拥有 130 年的历史，致力于为全球牙科行业及患者提供服务。登士柏西诺德开发、生产并销售综合解决方案，提供牙科、口腔保健产品并拥有世界顶尖品牌组合的其它医疗设备耗材。登士柏西诺德的产品提供创新、优质且有效的解决方案，推进病患保健并传递更优质更安全和更快捷的牙科产业服务。登士柏西诺德的全球总部位于美国北卡罗来纳州的夏洛特市。公司的股票在美国纳斯达克证券交易所上市，股票代码为 XRAY。

坚持人尽其才

时至今日牙科的发展迅速，但我们致力将它发展的更好。我们的员工有着对于创新的热情并承诺将其运用于提升口腔健康。我们以卓越表现和个人责任感为生活目标，在一支全球化团队中为了牙科患者的健康和牙科专业人士的服务，互相激励发挥个人的最大能力。如果您想要在一个塑造行业发展的团队中成长和发展，我们期待优秀的您的加入。

如果您在Dentsply Sirona工作您会获得：

快速的提升发展-正如我们致力于最优的专业领域发展

更优的表现-因为您身处于推动高绩效的企业文化中

塑造行业发展-您将与作为市场领导者的我们一起持续推动创新

创造不同-您会与我们共同提升全球的口腔健康

What We Are Looking For - Scope of Role

We are looking for an experienced and talented Senior Regulatory Affairs Manager to join our team. This individual will：Be responsible for regulatory affairs operation to ensure product registration and perform regulatory affair activities under company’ policies and standard operating procedures, and other applicable laws and regulations.

负责法规事务并执行产品注册事务并确保产品注册符合公司政策、标准操作流程以及其他适用的法 律法规。

What Will You Do - Responsibilities for Employment

• Establish and implement registration strategy to achieve approval for Suzhou factory products and other products .制定并执行注册策略，完成苏州工厂产品和其他产品注册审批。
• Build the China local SOPs on regulatory operations and focus on implementation.制定并执行产品的注册操作流程。
• Work with GBU RA, R&D, QA and related department to prepare registration submissions (including arrange and following up type testing, preparing registration files etc.), apply the registrations obtain approval of timely. 与GBU RA，研发、质量保证和相关部门合作，准备注册文件(包括安排和跟进型式试验，准备注册 文件等),提交注册并及时获得批准。
• Acts as the Regulatory partner for Suzhou factory to provide regulatory assessment and related affairs support.对所苏州工厂产品提供相应的法规支持。
• Interact with NMPA or local MPA on registration requirements and monitor changes to requirements.与NMPA或当地药监局就注册要求进行沟通，并跟踪相关要求的变化。
• Independently manages and monitors multiple complex and diverse short term and long term projects.独立管控多个复杂的短期和长期项目。
• Raise up and make assessment for specific issues, milestones, or status changes.提出并分析重要的问题，时间节点和变化。
• Manages the NMPA or local MPA regulatory review of IFU, label, clinical protocols and clinical reports for products that are under his/her responsibilities.依据NMPA或当地药监局医疗器械法规要求对所负责产品的说明书、标签、临床方案、临床 报告进行合规性检查。
• Monitors regulatory and Standards developments affecting DentsplySirona product he/she is responsible for.跟踪所负责产品的相关法规和标准更新和变化。
• File internal regulatory documentation.存档内部法规事务文档。
• Share regulatory affairs best practice with the team and provide necessary trainings to internal employees在团队内分享成功经验并向内部员工提供必要的法规事务培训。

Who You Are - Qualifications

Education 教育背景:

• Bachelor degree or above, major in equipment, electrical, computer science is preferred. 本科及以上学历，设备，电子，计算机相关专业优先

Experience 经验:

• Minimum 10 years’ regulatory and at least 6 years’ experience in equipment and software regulatory affairs, familiar with medical device regulations and equipment (including software) registration process and requirements, independently complete complex product changes (software upgrades, etc.) and new product registration experience is preferred. 至少10年注册经验并最少6年设备和软件监管事务工作经验，熟悉医疗器械法规和设备和软件 注册流程和文件要求，独立完成产品进口/国产设备和软件注册并最好有Al产品注册经验。
• Independent Software and equipment registration experience is preferred. Familiar with process and requirements of NMPA and local MPA(Jiangsu)is preferred. 有Al注册经验优先。熟悉国药局和江苏地方药监的流程和要求的优先。

Specific Knowledge /skills 具体专业技能 ：

• Possess a high degree of honesty with a track record built on success stories and sound ethics.具有成功案例及良好的道德规范背景下，拥有高度的诚信
• Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies. Professional knowledge on relevant standards and regulations.充分理解国内现有的法规操作和制度，不同法规主体的权力结构以及关系。具有相关标准和法规的专业知识。
• Able to work with a keen sense of urgency and priority tasks.具有敏锐的对任务的紧迫感和优先级观念。
• Strong inter-personal skills and good communication skills.良好的人际交往和沟通能力
• Hard working, good ability to learn, detail oriented, accountability 勤奋并乐于学习，注重细节，有责任心
• Fluent English in writing and speaking.熟练的英语听说读写能力

How We Lead the DS Way - Key Leadership Behaviors

• Actively articulates and promotes Dentsply Sirona’s vision, mission and values.
• Advocates on behalf of the customer.
• Promotes high performance, innovation and continual improvement.
• Consistently meets Company standards, ethics and compliance requirements.
• Clear and effective communication with stake holders, which span across multiple levels, socio-geographic areas and functional expertise.

登士柏西诺德提供平等的就业机会，反对就业歧视。所有符合资格的申请人都将纳入候选人的考虑中，不分种族、肤色、宗教、性别、国籍、年龄、性取向，不歧视残疾人和退伍军人。我们非常感谢您对登士柏西诺德的关注。如果您填写在线申请时因为身体不便需要帮助，请发送“求助申请”到[e-mail]。请确保邮件主题含有“求助申请”。