骨科产品评估员（认证机构）
Product Assessor for Orthopaedic (Notified Body)
作为产品评估员，您将在严格遵循欧洲医疗器械法规（EU MDR 2017/745）和英国医疗器械法规（UK MDR 2002）以及IIa/IIb和/或III类设备的前提下，负责进行骨科产品评估和技术文档审查。
主要职责：
- 在相关委员会法规代码下，对非主动式骨科医疗设备进行详尽的技术和临床评估，并有可能将专业知识扩展到牙科设备。
- 识别并纠正设备技术文档与适用要求不符的情况。
- 支持SGS内部的CE和UKCA标志认证活动。
- 参与初级员工的培训和资质评定，并开发全面的培训材料。
- 就产品评估与团队成员、客户和其他利益相关者进行有效沟通，努力降低医疗器械认证相关的监管风险。
- 确保对计划工作进行认真管理，以保持交付的及时性和效率。
我们寻找具备以下条件的候选人：
- 4年以上骨科产品领域或相关领域的专业经验，涵盖设计、制造、审计或研究等职位。关键的是，至少两年应直接参与骨科产品的设计、制造和测试，或在需要深入了解这些产品或技术科学原理的职位上工作。
- 熟悉骨科产品的基本标准。
- 具有为认证机构/通知机构（担任技术文档审查员）进行骨科产品评估的经验者优先。
- 相关学科（如医学、生物医学工程或生物医学科学）的硕士、博士或同等学历，最好专注于骨科设备。
- 熟练使用现代电子通信平台。
- 优秀的英文书面能力，对于审查和查询技术文档评估报告至关重要。
- 具备独立学习的能力。
- 优选：具备监管知识——了解欧洲医疗器械法规（EU MDR 2017/745）和英国医疗器械法规（UK MDR 2002），并熟悉MDA/MDN/MDS等MDR相关代码，详见委员会实施法规（EU）2017/2185。
查看英文原文
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
As a Product Assessor, you will play a pivotal role in conducting orthopaedic product assessments and technical documentation reviews in strict adherence to European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and for Class IIa/IIb and/or Class III devices.
Key Responsibilities:
· Conduct thorough technical and clinical assessments of non-active orthopaedic medical devices under relevant commission regulation codes, with potential to extend expertise to dental devices.
· Identify and rectify instances where device technical documentation deviates from compliance with applicable requirements.
· Provide support for CE and UKCA marking activities within SGS.
· Contribute to the training and qualification of junior staff and develop comprehensive training materials.
· Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimise regulatory risks associated with medical device certification.
· Ensuring diligent management of scheduled work to maintain timeliness and efficiency in deliverables.
We are seeking an experienced candidate with:
· 4+ years of professional experience in the orthopaedic products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, a minimum of two years should be directly involved in the design, manufacturing, and testing of orthopaedic products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies.
· Understanding of essential standards for orthopaedic products.
· Prior experience in conducting orthopaedic product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous.
· A Master's degree, PhD, or equivalent in a related discipline, such as medicine, biomedical engineering, or biomedical science, preferably with a focus on orthopaedic devices.
· Proficiency in modern electronic communication platforms.
· Strong written English skills essential for reviewing and querying Technical Documentation assessment reports.
· Demonstrated ability to learn independently.
· Desirable: Regulatory Acumen - knowledge of the European Medical Device Regulation (EU MDR 2017/745) and the UK Medical Device Regulation (UK MDR 2002) and familiarity with medical device codes MDA/MDN/MDS for MDR as outlined in Commission Implementing Regulation (EU) 2017/2185.
Why SGS?
· Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
· Enjoy a flexible schedule and work model.
· Access SGS University and Campus for continuous learning options.
· Thrive in a multinational environment, collaborating with colleagues from multiple continents.
· Benefit from our comprehensive benefits platform.
Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.
Please share your CV in English. The role is fully remote. People from other countries can apply as well.