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Regulatory Program Manager

Apple· Hardware
Apply on company site
Hybrid (Beijing; Shanghai)Posted 2mo ago

About the role

Role supporting Apple’s health initiatives within the medical device portfolio, focusing on regulatory and medical device policy efforts in China and the APAC region. Manages global medical device submissions, launches, design changes, and cross-regional health initiatives, coordinating with internal teams, regulators, clinical partners, and institutions.

Responsibilities

  • 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

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 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

Skills

Required:Regulatory program managementStakeholder engagementCross-regional coordinationProject management software
Last updated Oct 16, 2026. Interested? Apply on the company site.

About Apple

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

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