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Regulatory Program Manager
AppleBeijing, Beijing, China8+ years
Apply Our ever-evolving suite of products are helping our users lead healthier lives.
Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health, strengthening our commitment to leave the world better than we found it.
This role supports Apple's broader health initiatives within the medical device portfolio, directly contributing to our users' healthier lives worldwide. You will support our relationships across Apple's diverse internal teams, as well as regulators, clinical partners, and institutions across China and the APAC region. This work will drive regulatory and medical device policy efforts, strengthen regional clinical and scientific engagement, and enable global feature availability.
The Program Manager's responsibilities include providing comprehensive support for global medical device submissions, product launches, design changes, medical device policy interactions, and cross-regional health initiatives, with a focus in China and APAC.
- Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for medical device portfolio
- Support broad health initiatives by coordinating cross-functional programs that advance Apple's medical device strategy across regions
- Support China and APAC KOL engagement strategies — identifying, cultivating, and maintaining relationships with key opinion leaders, clinicians, and institutions across the region to support medical device regulatory and policy objectives
- Plan and execute engagements and events across China and APAC in support of medical device policy priorities alongside various Apple teams
- Establish a robust understanding of the overall critical path to coordinate medical device regulatory activities and resolve problems alongside cross-functional partners
- Communicate program status and escalate risks to a variety of stakeholders
- 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 devices and/or digital health
- Solid understanding of medical device regulatory and policy processes for different device classes, with familiarity across China and APAC markets
- Experience building and managing relationships with Key Opinion Leaders, clinical institutions, or scientific advisory networks in support of medical device programs, ideally within China and APAC
- Demonstrated experience planning and executing engagements, events, or partnership programs with external stakeholders in a medical device context
- Proven track record of driving medical device regulatory submissions and launches 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
- Hands-on experience in the use of project management and reporting software
- Master's degree, preferably in engineering, science, business or equivalent field
- 10+ years of program/project management experience in a regulated industry, preferably in medical device, clinical studies, and/or digital health
- Established network of China and APAC KOLs, clinical partners, or medical device regulatory contacts
- Experience planning and hosting advisory boards, conferences, or regional stakeholder events focused on medical device policy
- Track record of developing and managing strategic partnerships with clinical, academic, or industry organizations in the medical device space
- Proven track record of driving quality system updates and medical device regulator engagements
- Experience coordinating regional advisory boards, clinical partnerships, or scientific engagement programs
- Experience with implementation of tools and systems for process management
- Requires travel
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