Back

SHDM Sr RA Manager

Job Description

Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. 

任务/职位简述 Mission/Position Headline:
Oversee and  manage submission for obtaining and maintaining regulatory approvals and licenses  for all China locally made IVD reagent products, including products made by ODM/OEM model,   .
监督和管理所有中国本土IVD试剂产品的监管审批和许可的提交, 包括ODM/OEM 模式生产的产品。

职责领域 Areas of Responsibilities:
• Interface with a variety of functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including labeling requirements, registration requirements and timing, and expectations of the regulatory bodies.
跨多部门的合作,提供有关产品生命周期中问题管理的监管指导,包括标签要求、注册要求和时间安排以及监管机构的期望等。

• Develop strategies to ensure proactive planning to be compliant with new requirements and new regulations in China, and set priorities for those activities.
制定产品注册策略,确保主动规划符合中国的新要求和新法规,并为这些活动设定优先级。

• Be accountable for overall registration process in China inclusive of CFDA regulation requirement interpretation, registration activities planning and implementation,  other activities necessary for successful registration of products in China.
负责中国的整体注册流程,包括CFDA法规要求的解释、注册活动的规划和实施,以及在中国成功注册产品所需的其他活动。

• Monitor and communicate new regulatory requirements to the affected functional groups through coordination with LD QT  and US project team. 
通过与西门子诊断的质量部和美国项目团队的协调,监控并向受影响的职能部门传达新的监管要求。

• Interface with a variety of functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including labeling requirements, registration requirements and timing, and expectations of the regulatory bodies.
跨多部门的合作,提供有关产品生命周期中问题管理的监管指导,包括标签要求、注册要求和时间安排以及监管机构的期望等。

• Develop strategies to ensure proactive planning to be compliant with new requirements and new regulations in China, and set priorities for those activities.
制定产品注册策略,确保主动规划符合中国的新要求和新法规,并为这些活动设定优先级。

• Be accountable for overall registration process in China inclusive of CFDA regulation requirement interpretation, registration activities planning and implementation,  other activities necessary for successful registration of products in China.
负责中国的整体注册流程,包括CFDA法规要求的解释、注册活动的规划和实施,以及在中国成功注册产品所需的其他活动。

• Monitor and communicate new regulatory requirements to the affected functional groups through coordination with LD QT  and US project team. 
通过与西门子诊断的质量部和美国项目团队的协调,监控并向受影响的职能部门传达新的监管要求。

• Be accountable for resource planning for project RA and direct related staff to run different activities in order to be successful in product registration in China. 
负责项目风险评估的资源规划,并指导相关员工开展不同的活动,以便在中国成功进行产品注册。

• Manage team of RA specialists  and CRA specialists  as they execute new product registrations including type testing and clinical trials in China.
管理RA专家和CRA专家团队,他们在中国执行新产品注册,包括型式试验和临床试验

• Set up overall product registration plan and report registration progress or technical concern to representative departments for earlier aware the situation.
制定总体产品注册计划,并向代表部门报告注册进度或技术问题,以便提前了解情况。

• Work closely with global and local regulatory affairs and other department to advise required documents and prepare regulatory submission, draft product technical requirements and be responsible for type testing related issues.
与全球和当地注册部门及其他部门密切合作,为所需文件提供建议,准备监管提交文件,起草产品技术要求,并负责与型式试验相关的问题。

• Work as liaison to local authority, timely deliver all necessary registration materials to authorities and follow up with authority to ensure rapid and timely approval of the product.
与地方当局保持联络,及时向当局提交所有必要的注册材料并进行跟进,确保产品的快速和及时批准。

• Other tasks assigned by superiors.
完成上级分配的其他相关工作。

经验Experience

• At least 10 years of registration experience in regulations for medical device and pharmaceutical industry and 5 years should be in IVD, preferred experience with quality system, CE or FDA.
至少10年医疗器械和制药行业法规注册经验,5年IVD经验,具有质量体系、CE或FDA经验者优先。
• Direct hands on experience and relationship with Shanghai FDA and good contact with Beijing CFDA will be plus
直接与上海FDA合作的经验以及良好的关系,并与CFDA保持良好联系。
• At least 5 years of management experience and demonstrated competence in personnel development 
至少5年的管理经验和在人员发展方面的能力
• Ability to prioritize and juggle multiple projects and thrive under pressure
能够优先处理多个项目并在可承担压力下工作
• Strong communication and presentation skills 
较强的沟通和表达能力
• Good oral and written English is required
需要良好的英语口语和书面表达

 

教育Education
Bachelor degree or above, major in regulatory affair, biology, biomedical engineering, medicine or related
本科或以上学历,监管事务、生物学、生物医学工程、医学或相关专业


Our global team: 
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. We aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
 
Our culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
 
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. 

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Full / Part time: Full-time

Can't find what you are looking for?