Apple Seeks to Hire “Regulatory Project Manager” to Manage Future Apple Watch Health Features

Apple is looking to hire a “regulatory project manager” to join its growing healthcare team, as first noted in a report from MyHealthApple. The job posting is for a position within the hardware team and the person would be responsible for leading the work on a Class II medical device and associated regulatory barriers.

As detailed in the report, Class II medical devices present a “moderate to high risk to the patient and / or user”. Apple Watch’s irregular heartbeat and ECG characteristics are considered Class II, but the characteristics have only been “approved” by the FDA and have not actually garnered FDA approval. The Apple Watch Series 6 blood oxygen monitor did not require FDA approval or clearance because Apple markets it as a “wellness” tool, not a tool capable of diagnose or treat medical conditions.

The new job offer at Apple is for a “regulatory project manager” in the “Hardware” team, working on health and wellness products for iPhone and Apple Watch. Qualifications for the position include:

  • 5+ years of regulatory affairs experience with a minimum of 3 years in a project management role.
  • Proven experience in conducting regulatory submissions and approvals.
  • Experience working with software engineering projects.
  • You have worked with a digital health product or a Class II medical device with a strong software element for the product.
  • Strong understanding of regulatory submission requirements for FDA Class II medical devices in the United States and internationally.
  • You keep up to date on regulatory requirements including FDA and EU.
  • You have the ability to optimally advance multiple projects simultaneously.

Apple said the successful candidate “will lead projects requiring regulatory approval to help launch breakthrough technologies for Apple.” The person will be “responsible for leading a large, multi-functional team in project development in engineering, regulatory and clinical organizations,” writes Apple.

Apple’s efforts to expand the regulatory team come as Apple supplier Rockley recently announced a comprehensive “clinical wrist” digital health sensor system for non-invasive blood sugar measurement. The feature isn’t expected to arrive on the Apple Watch Series 7 this year, but it’s something Apple is exploring.

The full report of MyHealthApple worth reading for more details on regulatory hurdles for health products.

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About Byron G. Fazio

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