Compliance & Certification Officer / 合规与认证专员

苏州圆才企业管理服务有限公司

江苏省苏州市相城区
长期
全职

9天前

本科不限年龄不限经验五险一金工作性质全职工作地点苏州相城区职位描述8/25发布 ~ 2026/08/22截止Diagnogen Hong Kong is establishing a new IVD factory in Suzhou, China. As production will be carried out through CDMO partnerships, this role will focus on managing and implementing regulatory and compliance processes to ensure both the company and its CDMO partners achieve ISO and CE certifications in the shortest possible time. The officer will hold overall responsibility for obtaining all certifications required by the company.香港Diagnogen公司正在中国苏州建立一家新的体外诊断工厂。由于生产将通过CDMO合作伙伴完成，本职位将专注于管理和实施法规及合规流程，以确保公司及其CDMO合作伙伴在最短时间内获得ISO和CE认证。该专员将全面负责公司所需的所有认证。Key Responsibilities / 主要职责:Lead and coordinate compliance processes for CE certification, ISO 9001, and ISO 13485.主导并协调CE认证、ISO 9001和ISO 13485的合规流程。Take full responsibility for obtaining all company certifications required for operations and market access.全面负责公司运营和市场准入所需的所有认证。Implement ISO processes within contracted CDMO manufacturing companies to ensure compliance with Diagnogen and international standards.在合同CDMO生产企业中实施ISO流程，以确保符合Diagnogen和国际标准。Prepare and maintain all required documentation for certification applications, audits, and approvals.准备并维护认证申请、审核和批准所需的所有文件。Establish and manage a systematic and accurate documentation archive to ensure readiness for certification body inspections.建立并管理系统且准确的文档档案，以确保在认证机构检查时可随时使用。Manage regulatory applications and audits with Notified Bodies (NB).管理与公告机构（NB）的法规申请和审核。Liaise with EC-REP representatives, including existing partners such as Obelis (Belgium).与欧洲授权代表（EC-REP）保持联系，包括现有合作伙伴如比利时Obelis公司。Monitor and guide CDMO partners to meet GMP, ISO, and CE-IVD requirements.监督并指导CDMO合作伙伴，以满足GMP、ISO和CE-IVD要求。Train CDMO and internal staff on compliance documentation and audit preparation.对CDMO和内部员工进行合规文件和审核准备的培训。Provide regular compliance and certification progress reports to Diagnogen Hong Kong HQ.定期向香港Diagnogen总部提交合规和认证进度报告。Qualifications / 任职资格:Bachelor's degree in Quality Management, Regulatory Affairs, Engineering, or related field.质量管理、法规事务、工程或相关领域的学士学位。3-5 years of proven experience in achieving ISO 9001, ISO 13485, and CE certification in medical/IVD industries.在医疗/IVD行业中获得ISO 9001、ISO 13485和CE认证的3-5年工作经验。Strong knowledge of GMP, ISO standards, and European regulatory frameworks.熟悉GMP、ISO标准及欧洲法规框架。Demonstrated ability to implement ISO processes in external CDMO partner companies.具备在外部CDMO合作企业中实施ISO流程的能力。Experience in preparing and archiving certification documentation and working with European Authorized Representatives (e.g., Obelis, Belgium).具有准备和归档认证文件的经验，并能与欧洲授权代表（如比利时Obelis公司）合作。Excellent documentation, communication, and audit preparation skills.优秀的文档编制、沟通和审核准备能力。Proficiency in Mandarin and English.精通中文和英文。Salary & Benefits / 薪资与福利:Base Salary: Negotiable.基本工资：面议Performance Bonus: Additional bonuses will be awarded upon successful achievement of ISO 9001, ISO 13485, and CE certifications.绩效奖金：在成功获得ISO 9001、ISO 13485和CE认证后将发放额外奖金。Location & Reporting / 工作地点与汇报:

Work Location: Suzhou, China

工作地点：中国苏州

Reporting To: Diagnogen Hong Kong Headquarters

汇报对象：香港Diagnogen总部

公司介绍苏州圆才企业管理服务有限公司是园区政府授权的国资公司，是苏州工业园区人力资源开发有限公司的下属全资子公司，主要从事人事代理、劳务派遣、招聘外包、岗位外包等业务，是园区内最大最正规的人力资源服务机构。
我们遵循“专业、速度、沟通、品质”的文化价值观，以帮助我们的客户提高人力资源管理效率从而使企业实现最大增值为我们的最终任务，我们的服务在苏州人力资源服务领域处于领先地位。基本信息公司名称苏州圆才企业管理服务有限公司所在地苏州工业园区投资方新建元集团所属行业中介服务企业类型国有企业投资规模280万人民币地址苏州工业园区旺墩路168号市场大厦2楼

O・HR 圆才

立即申请