Apple is looking to hire a “regulatory project manager” to join its ever-growing Health team, as first detailed in a report from MyHealthyApple. The job posting is for a position on the Hardware team and the person would be responsible for leading the work on a Class II medical device and the associated regulatory hurdles.
As detailed in the report, Class II medical devices have a “moderate to high risk to the patient and/or user.” The Apple Watch’s irregular heart rhythm and ECG features are considered Class II, but the features have only been “cleared” by the FDA, and have not actually recovered FDA approval. The Apple Watch Series 6’s blood oxygen monitor did not require FDA approval or clearance because Apple is marketing it as a “wellness” tool, not one that can diagnose or treat any medical conditions.
The new job posting at Apple is for a “Regulatory Project Manager” on the “Hardware” team, working on Health and Wellness products for iPhone and Apple Watch. The qualifications for the job include:5+ years of experience in Regulatory Affairs with a minimum of 3 years in a project management role. Proven track record of driving regulatory submissions and approvals. Experience working with software engineering projects. You have worked with a digital health product or medical device Class II with a strong software element to the product. Solid understanding of regulatory submission requirements for FDA Class II medical devices in both the US and internationally. You keep up to date on regulatory requirements, including FDA and EU. You have the ability to optimally drive progress on multiple projects simultaneously.
Apple says the person chosen for this role will “lead projects requiring regulatory approval to help launch ground breaking technologies for Apple.” The person will be “responsible for leading a broad multi-functional team in developing projects across the Engineering, Regulatory, and Clinical organizations,” Apple writes.
Apple’s efforts to expand the regulatory team come as Apple supplier Rockley recently announced a complete full-stack, “clinic-on-the- wrist” digital health sensor system for non-invasive blood sugar measurement. The feature is not expected to come to the Apple Watch Series 7 this year, but it’s something Apple is exploring.
The full report from MyHealthyApple is worth a read for more details on the regulatory hurdles of health products.
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