Description

Clinical Validation Specialist

寻找一位具备放射医学或医学影像专业背景、拥有10年以上CT临床应用经验及7年以上医院影像诊断经验的资深临床专家，能够代表最终用户视角推动CT产品临床验证、图像评估及法规合规工作，并为研发团队提供专业临床指导。

To test CT systems from an end user perspective by performing the related clinical workflow in a simulated environment or real use environment.
To prepare the validation related documents in English, peer review other design documents and provide timely feedback.
To provide clinical expert opinion regarding the CT workflow, image quality and performance needs to R & D engineer.
To establish and maintain good relationships with clinical experts, hospitals and governments to co-ordinate site visits, obtain clinical data and information and organize expert visits.

职位概述：

Responsibility工作职责

Responsible for Design Validation Plan, Design Validation Protocols and Design Validation Report. Defines the entry and exit criteria for Design Validation.
To organize and perform internal and external validation activities, to validate the clinical satisfaction and acceptability of product and function under clinical circumstances.
To establish and maintain good relationships with clinical experts, hospitals and governments according to PDLM and project requirements, therefore, to co-ordinate site visits, obtain clinical data and information and organize expert visits.
To join risk analysis for clinical feedback according to Risk Evaluation process.
Has overall responsibility for the design validation function and outputs, overall planning, coordination and tracking of the Design Validation activities and act as SME during internal and external Audits.
Responsible for Design Validation Traceability Matrix, generating and providing validation evidence for different regulatory bodies (FDA, NMPA, CE, etc.) as per the company QMS process.
Has ability to participate in image review and can give observation/feedback independently
Translate issues reported from the clinical sites into defects. Submit defects in the defect management tool.
Provides the training and guidance for the design validation’s clinical sites，Collects Design Validation Records and feedback from the clinical site and ensures they both adhere to good documentation practices.

工作职责：

负责制定设计验证计划（Design Validation Plan）、设计验证方案（Design Validation Protocol）和设计验证报告（Design Validation Report），并定义设计验证的准入和退出标准。
组织和执行内部及外部验证活动，在真实临床场景下验证产品及功能的临床满意度和可接受性。
根据PDLM流程和项目需求，建立并维护与临床专家、医院及政府机构的合作关系，协调医院现场验证、获取临床数据和信息，并组织专家评审活动。
根据风险评估流程（Risk Evaluation Process），参与临床反馈相关的风险分析工作。
对设计验证活动及交付物承担总体责任，包括验证活动的规划、协调和跟踪，并在内部及外部审核中担任领域专家（SME）。
负责设计验证追溯矩阵（Design Validation Traceability Matrix），依据公司QMS体系要求，为FDA、NMPA、CE等监管机构提供验证证据。
能够参与医学影像评审，并独立提出专业观察及反馈意见。
将临床现场反馈的问题转化为缺陷（Defects），并在缺陷管理系统中提交和跟踪。
为临床验证合作医院提供培训和指导，收集设计验证记录及反馈，确保符合良好文档规范（Good Documentation Practices）。

Requirements

7-years imaging diagnosis/imaging analysis experience in hospital
10 years of work experience in radiography technology which includes working with CT systems
Knowledge in imaging product principles. Skills in CT product category are preferable.
Knowledge and experience in CT photon counting technology is a plus point.
Knowledge of the progress and trends of imaging products and able to give instruction for product design and update.
Proficient in both written and spoken English.
Has soft skills in leading and organizing activities.
AI skills and usage is preferrable.

教育背景

资格认证

具备以下专业执业资格之一：

工作经验

专业能力

语言能力

软技能

其他要求

Clinical Validation Specialist