Regulatory/Quality Program Manager

at  Apple

SUMMARY

Posted: Jun 18, 2024
Weekly Hours: 40
Role Number:200554967
Our ever-evolving suite of Heath 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 business practices - strengthening our commitment to leave the world better than we found it. Do you want to help deliver the next amazing Apple product? Program Managers are responsible for leading a diverse multi-functional team in developing projects across the Engineering, Regulatory/Quality, and Clinical organizations. In this critical, highly visible role, you will lead projects requiring regulatory approval to help launch ground breaking technologies for Apple. Our teams feature a collaborative environment with creative people who care deeply about getting great products in the hands of our users. Are you passionate about truly changing health? Come, join us in crafting solutions the world doesn’t know of yet!

DESCRIPTION

The Program Manager will provide regulatory and quality support for product submissions, approvals, and launch readiness. You will work hand in hand with multi-functional teams and may provide individual contribution to meet the team’s objectives. You will be responsible for developing program timelines, tracking submission and quality system deliverables, and providing support for regulatory submissions, by coordinating with various internal and external team members. You will collaborate closely with multiple teams to drive global product launch readiness. In addition, you will drive day-to day program activities, generate and own reports and dashboards, and conduct risk assessments to meet overall program objectives. Responsibilities include: • Establish and handle Quality Design History File documentation timelines and successful execution across multiple cross-functional partners • Lead all aspects of regulatory submissions and approvals 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 raise risks to a variety of team members • Collaborate with external partners, vendors and consultants This is a site based role.

• BS/MS in Engineering, Biomedical Science or equivalent science degree.
• 8+ years of program/project management experience in medical devices
• Demonstrated expertise with medical device design controls and quality systems
• Proven track record of driving regulatory submissions, approvals, and launches with multi-disciplinary teams
• Outstanding communication and organizational skills. Ability to optimally lead multiple projects simultaneously

PREFERRED QUALIFICATIONS

• 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
• Solid understanding of regulatory process for different classes of medical devices in both the US and internationally
• May require occasional travel

• BS/MS in Engineering, Biomedical Science or equivalent science degree.
• 8+ years of program/project management experience in medical devices
• Demonstrated expertise with medical device design controls and quality systems
• Proven track record of driving regulatory submissions, approvals, and launches with multi-disciplinary teams
• Outstanding communication and organizational skills. Ability to optimally lead multiple projects simultaneousl