Regulatory Program Manager
Apple
Regulatory Program Manager
Apple
Designs phones, computers and their operating systems
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.
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
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
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.
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 escalate risks to a variety of stakeholders Establish and manage Quality Design History File (DHF) documentation timelines and successful execution across multiple cross-functional stakeholders
Apple designs and sells consumer electronics, from iPhone smartphones and Mac computers to tablets and wearable devices. Its operating systems manage apps and built-in functions for communication and work, while iCloud stores files and synchronizes data across devices. Customers buy additional digital services through subscriptions such as Apple Music and Apple TV, and developers distribute software through the App Store. Apple earns money from hardware sales, subscriptions and digital transactions, selling directly to customers and through retailers and mobile carriers around the world. It was founded in 1976 and has its headquarters in Cupertino, California.
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