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Apple Regulatory/Quality Program Manager United States, California, Cupertino 557200681
21.11.2024
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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 consultantsThis is a site based role.
Minimum Qualifications
- 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
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 $165,500 and $248,700, and your base pay will depend on your skills, qualifications, experience, and location.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 take affirmative action to ensure 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.
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