Regulatory Program Manager, Health

Apple; Cupertino (CA); On-site; USD 176,000 - 264,000; Full time

Benefits offered by this job

Employee stock programs

Stock Purchase Plan

Education reimbursement

Medical and dental coverage

Retirement benefits

Job summary

Apple Inc. in Cupertino, California is seeking a Program Manager to provide regulatory and quality support for submissions, launches, design changes, and policy engagements across medical devices and digital health products.

You will collaborate with regulatory, quality, clinical, marketing, and engineering teams to drive global launches, manage risks, and ensure on-time delivery of compliant health features.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Science, or equivalent
• 8+ years of program/project management in a regulated industry, preferably medical products/digital health
• Proven track record in regulatory submissions, quality system updates, regulator engagements, and launches with cross-functional teams
• Excellent communication and organizational skills with ability to manage multiple projects

Responsibilities

• Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities
• Coordinate the critical path and resolve issues with cross-functional partners
• Communicate program status and elevate risks to stakeholders
• Manage DHF documentation timelines and ensure quality across teams

Skills

Project management

Regulatory knowledge

Cross-functional leadership

Communication skills

Risk assessment

Education

BS in Engineering/Biomedical Science

MS in Engineering/Biomedical Science

Tools

PM software

Regulatory documentation tools

Job description

Cupertino, California, United States Software and Services

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.This role collaborates with regulatory, quality, clinical, marketing, and engineering teams to push health features to global launch. You will connect across diverse teams and drive new regulated health features, which have the potential to improve health outcomes for people around the world.

Description

The Program Manager will provide regulatory and quality support for regulatory submissions, product launches, design changes, and policy engagements. You will collaborate closely with multiple teams to drive global product launch, including regulatory submissions, design changes, and external engagement support. In addition, you will drive day-to-day program activities and timelines, generate and own reporting, and conduct risk assessments to meet overall program objectives.

Responsibilities

• Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for portfolios of work
• Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside cross-functional partners
• Communicate program status and elevate risks to a variety of stakeholders
• Establish and manage Quality Design History File (DHF) documentation timelines and successful execution across multiple cross-functional stakeholders

Minimum Qualifications

• Bachelor's degree (BS) in Engineering, Biomedical Science, or equivalent science degree
• 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health
• Proven track record of driving regulatory submissions, quality system updates, regulator engagements, and launches with multi-disciplinary teams
• Outstanding communication and organizational skills, with the 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
• Ability to be onsite weekly; this role is a hybrid, in-person position.
• May require occasional travel

Preferred Qualifications

• Master's degree (MS) in Engineering, Biomedical Science, or equivalent science degree
• Direct hands-on experience with Design Controls and Quality Systems
• Solid understanding of the regulatory process for different classes of medical devices in both the United States and international jurisdictions

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 $175,500 and $263,800, 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

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

At Apple, we believe accessibility is a fundamental human right. You’ll find that idea reflected in everything here — in our culture, our benefits and our digital tools. By welcoming as many perspectives as possible, we help you build a career where you feel like you belong.

Learn about accessibility in Apple’s workplace

Learn about reasonable accommodations for job applicants

Apple accepts applications to this posting on an ongoing basis.