岗位职责
- 业务支持：AI医疗产品/服务的本地化合规评审、合作协议审阅、商业模式合规论证
- 监管跟踪：持续跟踪 HK/SG 在 AI医疗器械、远程医疗、健康数据处理、大模型医疗应用等领域的立法与执法动态
- 合规体系建设：搭建数据跨境、算法透明度、SaMD注册认证等合规框架
- 监管应对：对接香港卫生署、新加坡 HSA/PDPC 等监管机构
- 跨境协调：管理外部律所，协调集团总部与海外团队 Business Compliance Support – Conduct in-depth compliance reviews for the localization of AI-powered healthcare products and services; review partnership agreements; and provide comprehensive compliance assessments and risk analyses for emerging business models. • Regulatory Monitoring – Continuously track legislative and enforcement developments in Hong Kong and Singapore regarding AI medical devices, telemedicine, health data processing, and LLM-based healthcare applications; proactively issue actionable compliance guidance to business teams. • Compliance Framework Development – Lead the design and implementation of core compliance frameworks covering cross-border data transfers, algorithmic transparency, and SaMD (Software as a Medical Device) registration/certification, ensuring end-to-end regulatory adherence across all operations. • Regulatory Engagement – Serve as the primary point of contact with key regulators, including the Hong Kong Department of Health, the Health Sciences Authority (HSA) of Singapore, and the Personal Data Protection Commission (PDPC), effectively managing inquiries, inspections, and ongoing dialogues. • Cross‑Border Coordination – Oversee the management of external counsel across jurisdictions, and coordinate legal and compliance matters between headquarters and overseas teams to ensure seamless execution of global strategies at the regional level.
职位要求
- 10年+法律工作经验，并且5年+在医疗健康或 AI/科技领域的法务工作经验
- 香港/新加坡任一法域法律资格
- 深入理解香港及/或新加坡监管体系，有实际落地经验
- 中英文工作语言（粤语加分）
- 对 AI/ML/LLM 等技术有基本理解，能和技术团队对话 • 10+ years of legal practice experience, with at least 5 years in the healthcare, AI, or technology sector. • Qualified to practice law in Hong Kong or Singapore (active bar membership in either jurisdiction). • Deep understanding of the regulatory landscape in Hong Kong and/or Singapore, with proven hands‑on experience in local compliance implementation. • Proficient in both Chinese and English as working languages; proficiency in Cantonese is a plus. • Solid foundational knowledge of AI/ML/LLM technologies, with the ability to communicate effectively with engineering and product teams on technical matters.
