Regulatory Project Manager
- 5+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health
- Solid track record of driving regulatory submissions, approvals, and launches with multi-disciplinary teams
- Outstanding communication and organizational skills. Ability to effectively lead 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
The Project 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 hands-on individual contribution to meet the team’s objectives. You will be responsible for developing project timelines, tracking project submission deliverables, and providing support for regulatory submissions by coordinating with various team members. You will collaborate closely with multiple cross-functional teams to drive global product launch readiness. In addition, you will drive day-to day program activities, generate and own reports and score cards, and conduct risk assessments to meet overall program objectives.
- Coordinate 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 project status and escalate risks to a variety of stakeholders
- Establish and handle Quality Design History File documentation timelines and successful execution across multiple cross-functional partners
Education & Experience
BS/MS in Engineering, Biomedical Science or equivalent science degree.
- - Experience with Design Controls and Quality Systems
- - 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 $97,700 and $162,800, and your base pay will depend on your skills, qualifications, experience, and location.
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