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Apple

Regulatory Program Manager

Posted 22 days ago

Apply on company site View full job

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.

Description
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.

","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

Preferred Qualifications
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

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 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

About Apple

Working at Apple means doing more than you ever thought possible and having more impact than you ever imagined.

Size: 10,000+ employees
Industry: Technology

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