Apple is currently looking to onboard a Regulatory Project Manager to assist with introducing new Class II medical device. The new job was posted on Apple’s career site last week.
As expected this is a role in ‘Hardware’ division and the project manager will be responsible for leading a broad multi-functional team in developing projects across the Engineering, Regulatory, and Clinical organizations.
As per the position description, the Project Manager will provide regulatory support for product submissions, approvals, and launch readiness. He/She will also work hand in hand with the regulatory team and may provide hands-on individual contributions to meet the team’s objectives.
Some of the key requirements for this new role include:
- 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.
- 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 with FDA/GMP/Quality Systems per ISO 13485 requirements
- Experience working with software engineering projects
It is unclear from the position description if this is related to a new product or if the new FDA regulatory filings are going to be more along the lines of Software as a medical device (SAMD).
There have been rumors that Apple may explore the area of metabolic health. Companies that collect data from minimally invasive glucose sensors and provide metabolic health insights currently are not required to pursue a FDA proceeding. Levels and Veristable are examples of this.
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Up until now, most software as a medical device (SaMD) has often been classified as a class I product but that has been changing based on new regulations.
Most Class II devices require Premarket Notification 510(k). Dexcom was the first company to have its G6 continuous glucose monitoring system (CGMS) classified as a class II device.
Apple’s earlier ECG and AFib related FDA filings were done via the DeNovo route. Numerous reports in the recent months show that Apple may have been working with Rockley photonics to evaluate new health sensors into its products.
- Apple hiring cardiologist with experience in clinical product development
- Apple hiring Senior Legal Counsel for Health Products
- Apple developing Apple-branded health hardware products
The Silicon Photonics based sensor platform from Rockley is expected to help with noninvasive glucose monitoring, blood alchohol detection and more but it still needs to pass thorough stringent studies and FDA regulations before it can offered on a consumer product.
We have been following Apple’s hiring in the health space and are not surprised with this new position since the company has been onboarding cardiologists, regulatory reg personnel, and clinicians over the last year.