Job Details

Role Number: 200625894-3401

Summary

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.

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

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

Pay & Benefits

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $172,100 and $258,600, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits. (https://www.apple.com/careers/us/benefits.html)

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

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 (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .