GQA 技术和法规审查员
GQA Technical and Regulatory Reviewer
我们致力于为人们和地球创造积极的改变。加入我们，也来做出改变！
全球质量与认证（GQA）技术与法规审查员
中国-居家办公，偶尔需要出差
职位简介
我们的法规服务GQA团队正在寻找一名GQA技术与法规审查员，负责为中国及全球的医疗器械/产品认证和QMS审核团队提供质量管理体系的管理职责。
职责
· 支持在中国及全球范围内法规服务QMS审核的政策决策和流程实施
· 支持ISO 13485认证/产品认证和CE方案，例如调查客户申诉、审核报告以及在监管机构审核期间提供支持
· 在资源允许的情况下，针对所有非CE的ISO 13485方案和产品认证方案，做出认证决定
· 维护参与中国认证方案所需的资格和注册，包括符合适用的CCAA能力和持续职业发展要求
· 参与小型改进项目，确保遵循相关程序
· 支持举办监管机构或认可机构的审核
· 为全球QMS审核员、技术专家、方案经理、销售、市场和其他BSI同事提供关于BSI医疗器械和产品认证QMS要求的建议和支持
· 如有必要，参与能力验证活动以支持审核员资格流程
要成功胜任该职位，您应具备：
- 工程、科学或相关专业的学士或硕士学位
- 熟悉中国QMS要求以及适用的法规和标准（特别是ISO 13485、17021、17065、MDD、AIMD和/或IVDD、MDR/IVDR和MDSAP要求）
- 在中国认证方案中具备CCAA认证审核员资格，包括CNCA和CCAA要求的应用和解释
- 了解中国认证方案治理、审核员资格和能力要求，以及CNCA认证规则的应用
- 具备良好的人际沟通和交流能力（书面和口头），中文和英文流利
BSI提供具有竞争力的全面薪酬包，在国际环境中从事独立且多样化的工作，
查看英文原文
We exist to create positive change for people and the planet. Join us and make a difference too!
Global Quality & Accreditation (GQA) Technical and Regulatory Reviewer
China- homebased, occasional travel required
About the role
Our Regulatory Services GQA team are looking for a GQA Technical and Regulatory Reviewer who will provide quality management system ownership to medical devices/product certification and QMS audit teams both in China and globally.
Responsibilities
· Support the roll out of policy decisions and processes for regulatory servicesQMS audits in China and globally
· Provide support of the ISO 13485 certification / product certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits
· Deliver certification decisions for ISO 13485 certifications and product certification schemes eligible, with a goal to being qualified across all non-CE ISO 13485 schemes and product certification schemes, where resource allows
· Maintain qualifications and registration required for participation in China certification schemes, including compliance with applicable CCAA competency and continuing professional development requirements
· Participating in smaller improvement projects ensuring appropriate adherence to procedures
· Support in hosting regulator or accrediting body audits
· Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices and product certifications
· Competence verifier activities to support the auditor qualification process, if appropriate
To be successful in the role, you will have:
- First or second degree in Engineering, Science, or related discipline
- A good understanding of QMS requirements as applied in China as well as applicable regulations and standards (ISO 13485, 17021, 17065, MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular)
- CCAA qualified auditor within China certification schemes, including application and interpretation of CNCA and CCAA requirements
- Knowledge of China certification scheme governance, auditor qualification and competence requirements, and the application of CNCA certification rules
- Excellent interpersonal and communication skills (written and oral) in Chinese and English
BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 15-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, maternity leave, nursing leave, paternity leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
Originally posted on Himalayas