苹果Regulatory Engineering Program Manager
任职要求
Minimum Qualifications • Bachelor’s degree, preferably in engineering, science, business or equivalent field • 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health • Proven track record of driving regulatory submissions and quality system implementations with multi-disciplinary teams • Outstanding communication and organizational skills. Ability to optimally manage multiple projects simultaneously • Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks • Independent self-starter who thrives in ambiguous environments • …
工作职责
The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions. - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners - Communicate program status and escalate risks to a variety of stakeholders - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
The Program Manager's responsibilities include providing comprehensive support for regulatory and quality activities in China and the APAC region. This includes product submissions, market initiatives, and policy interactions. - Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the portfolio - Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners - Communicate program status and escalate risks to a variety of stakeholders - Establish and manage Design History File documentation timelines and successful execution across multiple cross-functional stakeholders
THE ROLE AMD is seeking an experience program manager to lead governance and oversight of an outsource testing service lab to orchestrate and elevate the quality, consistency, and competitiveness of the AMD GPU software ecosystem on Linux. This role ensures strategic alignment, operational excellence, and audit compliance for testing AMD GPU products in the OTS lab.
The Tesla Internal Audit Team’s mission is to protect the company by calling attention to critical risks and driving management action to address those risks. Internal projects are driven by two guiding principles – Keep Tesla Safe and Enable Operational Excellence. The Team achieves its objective by collaborating with functional and business/product groups to identify areas of risk, making valuable recommendations on process and control improvements, cost reduction, and operational excellence. The Team is working in close collaboration with functional and business/product work groups to identify areas of risk, making valuable recommendations on process and control standardization, and influencing the decision-making process to drive change. The Role Tesla Internal Audit team is seeking an Internal Audit Program Manager with relevant operational and financial experience to support the Internal Audit team in the APAC region. This is a high visibility role where you will be interacting with all levels of personnel within the company. The ideal candidate will leverage the knowledge of audit, internal controls, financial and business operations to identify and evaluate critical business risks and relevant business and governance processes. The successful candidate, who should be able to demonstrate a “can do” attitude and “go getter” personality. Responsibilities • Lead APAC internal audit projects with focus on operation processes and could also evaluate, plan, execute, and report on assigned projects as an individual contributor • Present observations and recommendations to management for process and control improvement and facilitating management action plans • Champion a risk-based approach to independently evaluate, plan, perform, summarize, and communicate assigned risk assessments and audit activities • Lead special projects requested by the Audit Committee of the Board around internal control assessments, and special investigations • Prepare and provide written and oral reports, communications and/or presentations to management presenting observations and recommendations for internal control improvement and facilitating management action plans • Drive continuous improvement of the department by bringing leading practice frameworks, audit process improvements, and thought leadership • Coordinate with other risk management functions (e.g., Privacy and Regulatory Compliance) to minimize duplication of effort and maximize execution • Serve as a consultant across various functions related to Tesla’s automotive and energy business including but not limited to manufacturing, supply chain, financial services, vehicle sales, service, and delivery. • Develop strong relationships with business partners and stay abreast of emerging trends and accounting standard changes to assess impact on controls/procedures Qualification and
• - Establish and maintain project schedules, prioritize issues and track the details as well as be in touch with the big picture • - Collect high quality data and ensure study compliance to domestic / international regulations • - Responsible for tracking study heath, prioritize issues and escalate as needed between local teams and US-based team • - Assist with the creation, development, review, and finalization of study related documents such as operational plans, informed consent forms, etc. • - Responsible for maintaining communication with external sites and/or CRO to ensure tracking and management of safety events and study monitoring • - Assisting in in-region regulatory team EPM activities