Regulatory Project Manager - OUS
Santa Clara Valley (Cupertino), California, United States
Our ever-evolving suite of Heath and Wellness products for iPhone and Watch 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? Project Managers (PMs) are responsible for leading a broad multi-functional team in developing projects across the Engineering, Regulatory, 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!
- 5+ years of experience in Regulatory Affairs with at least 3 in a Project Management role.
- Consistent track record of driving regulatory submissions and approvals, and product launches around the globe.
- Experience working with software engineering projects.
- Worked with a digital health product or medical device Class II with a strong software element to the product.
- Working knowledge of regulatory submission requirements for FDA Class II medical devices in both the US and internationally.
- Remain up to date on regulatory requirements, including FDA and EU.
The Project Manager will provide regulatory support for both domestic and international product submissions, approvals, and launch readiness. You will work hand in hand with the regulatory team and may provide hands-on individual contribution to meet regulatory team’s objectives. You will be responsible for tracking project submission deliverables and provide support for the US and OUS submissions by coordinating with various team members to obtain necessary documents required for timely submissions. You will collaborate closely with multiple cross-functional teams to drive product launch readiness internationally. In addition, you will drive day-to day program activities, generate and own monthly Global Regulatory submission and approval score cards, and conduct risk assessments to meet overall program objectives for development projects. General responsibilities: - Lead all aspects of international product launch readiness for Apple’s Health products. - Coordinate activities and problem solve for Regulatory and project team. - Coordinate regulatory submissions and approvals internationally. - Coordinate with international regulatory team members on product changes and regulatory notification/approval requirements. - Build and update regulatory responsible quality system procedures as required (i.e. SQP/SOPs).
Education & Experience
BS/MS in Engineering, Biomedical Science or equivalent science degree.
- - Experience with FDA/GMP/Quality Systems per ISO 13485 requirements
- - Ability to efficiently drive progress on multiple projects simultaneously.
- - Highly detail oriented.
- - Outstanding communication and organizational skills.
- - Excellent analytical and problem-solving abilities.
- - Ability to detect and mitigate risk.
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants.