Regulatory Program Manager

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.

## 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

## 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