Regulatory Program Manager - Health
Our ever-evolving suite of health and wellness products are helping our users live more active, 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.
The Regulatory Program Manager supports the launch of regulated health features, directly contributing to our users' healthier lives worldwide. You will build relationships across Apple's diverse teams to support regulatory efforts and enable global feature availability.
Description
The Program Manager will provide comprehensive support for all global submissions, product launches, design changes, and policy interactions. Responsibilities include:
• Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the medical device portfolio
• Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners
• Communicate program status and escalate risks to a variety of partners
• Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders
This is a site-based role and may require occasional travel.
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 products and/or digital health
Consistent track record of driving quality system updates and regulator engagements
Experience with implementation of tools and systems for process management
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
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 understanding of regulatory process for different classes of medical devices in both the US and internationally
Consistent track record of driving regulatory submissions and launches with multi-disciplinary teams
Outstanding communication and organizational skills. Ability to efficiently handle multiple projects simultaneously
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .
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Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion
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