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苹果Regulatory Engineering Program Manager

社招全职Hardware地点:北京状态:招聘

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
• …
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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
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