苹果Principle Regulatory Affairs Associate
任职要求
Minimum Qualifications
• Bachelor's degree or equivalent in science or engineering.
• 7+ years experience in regulatory affairs.
• Fluent in both English and Chinese
Preferred Qualifications
• Masters / PhD / post-secondary education preferred.
• Experience working with the SaMD product or wearable technology.
• Executive poise and presence, including a track record of positively influencing decisions and teams.
• Demonstrable background in being autonomous and being able to clearly work towards establish goals …工作职责
• Key responsibilities include: • - Developing submission strategy for assigned product(s) • - Collaborate with subject matter experts to draft submission documents (e.g. Product Technical Requirements document, Clinical Evaluation Report, etc) • - Lead in country medical device type testing • - Oversee submission review progress • - Lead technical discussions with the regulatory agency and the test lab
1. Responsible for the overall architecture design and planning of the chassis by wire, and formulate technical routes and programs; 2. Work closely with hardware engineers and software engineers to design the electrical and electronic architecture, and develop control strategies and algorithms to realize the intelligent control of the chassis by wire system; 3. Conduct safety analysis based on chassis by wire functional architecture and definition, develop safety requirements at function level , and participate in the safety design of each function; 4. Be responsible for data collection and analysis during the testing process, timely detection and resolution of problems during testing, and optimization and improvement of the system; 5. Participate in fault diagnosis and troubleshooting of chassis by wire system, establish the FMEA system, and formulate the corresponding fault response measures; 6. Participate in the discussions of chassis by wire regulations or technical standards in Europe and globally, translate the content into system or safety design requirements, and into the software and hardware design of EMB. Represent Li Auto in the regulatory or technical standard discussions to propose suggestions or comments.
1.Conduct market and competitive analysis in the assigned country to provide timely intelligence support to headquarters, facilitating the formulation of accurate business strategies and market positioning.（开展所属国家的市场及竞争情况调研分析，为总部提供及时的信息支持，帮助制定准确的业务策略和市场定位。） 2.Manage partner acquisition in the assigned country in compliance with regulatory principles, onboarding high-potential partners to support rapid business expansion. Establish and maintain comprehensive and confidential records for all approved partners.（在遵循合规原则下，负责所属国家的合作商招商管理，引入优质意向商，支持业务的快速发展。同时，建立各国准入商的档案，确保合作商信息的完整性和保密性。） 3.Collaborate with front-line, security, and quality control teams to investigate and resolve partner-related risk incidents, ensuring swift and closed-loop handling. Conduct interviews for major risk events to uphold effective risk control.（协同一线管理、安全管理、质控管理等团队，负责所属国家合作商风险事件的调查与处置，实现风险事件的快速闭环处理。对合作商的重大风险事件进行约谈，确保风险控制的有效性。） 4.Work with the vehicle and equipment management team to develop and implement strategies for partner equipment coverage and cost optimization, ensuring compliance while driving continuous cost reduction.（协同载具装备管理组，制定并实施所属国家合作商装备覆盖及成本优化策略，确保装备合规性的同时，实现成本的持续降低。） 5.Coordinate with the training team to organize, deliver, and monitor training programs for local partners, tracking effectiveness to ensure successful implementation of training content.（协同培训管理组，组织和协调所属国家合作商的培训活动，并进行督导和效果追踪，确保培训内容的有效传达和落实。）
• You will participate in local/regional standards association meetings in CCSA • You will participate in 3GPP standards meetings • You will develop and run C/C++ simulations to help model the design and performance of PHY algorithms and RF performance for 5G • You will be part of a team defining and doing research of next generation standards
- Lead the development and execution/develop of the company’s Enterprise Risk Management (ERM) strategy, ensuring it is aligned with the overall business strategy and risk appetite, in accordance with business conditions, the regulatory environment, and industry trends. - Develop and maintain a comprehensive ERM framework, including risk identification, assessment, mitigation, and monitoring processes. - Collaborate with the Executive Team and department heads to integrate risk management practices across all functions and business units. Collaborate to ensure the effective execution of risk controls and advise on risk reduction opportunities & best practices for risk management. - Provide thought leadership and guidance on emerging risks, including operational, strategic, compliance, and reputation - Oversee the development and testing of business continuity plans and disaster recovery procedures to ensure organizational resilience in the event of disruptions, and oversee the management of crisis situations, ensuring that risk mitigation measures are implemented swiftly and effectively. - Foster a risk-aware culture across the organization by ensuring effective communication of risk management policies, guidelines, and procedures.