Legal Counsel – Health Products Regulatory – 200566836 -Washington DC, District of Columbia, United States

Are you passionate about creating powerful health tools and improving the lives of others? If so, we have an opportunity for a skilled lawyer like you to join our team of diverse, creative, and passionate people. Join a group of attorneys supporting the development of Apple’s health products and work with Apple’s engineering, marketing, operations, clinical, and regulatory teams to help create and introduce Apple products and services to the world.

At Apple, our ever-evolving suite of Health and Wellness products are helping our users live more active, healthier lives. Imagine what you could do here working alongside dynamic, inspiring people to develop truly innovative, industry-defining technologies. As a part of our Products & Regulatory Legal Group, you’ll help uphold Apple’s high ethical and corporate standards, while providing crucial advice to our in-house partners across the globe. Working for a company that focuses on innovation and redefining what is possible within the health industry means you’ll be challenged to creatively apply your expertise to rare and often unexplored areas of the law.

In this role, you will join a team of attorneys in the Products & Regulatory Legal Group who support global business partners across Apple that are developing its health technologies, products, and services. You will collaborate with other legal groups and advise engineering, marketing, operations, clinical, and regulatory business teams on a variety of matters related to health-related features and products, including product development, regulatory compliance, research collaborations and partnerships, and human subjects research. You will help formulate legal and regulatory strategies and advise on and provide novel solutions to mitigate risks presented by the development of innovative health technologies. You will also draft and negotiate agreements facilitating the design, development, and distribution of Apple’s health technologies. As part of our organization, you will monitor the progress of health regulations and policies and respond to regulatory agency inquiries.

4+ years of experience advising on regulatory compliance issues specific to medical device and wellness features, including counseling related to device design, product marketing, and distribution of digital medical products.Skilled at advising business teams and leadership on complex legal risks related to the development, commercialization, and post-market compliance of software-based medical devices.Experience interacting with and supporting regulatory submissions to the FDA and equivalent agencies outside the U.S.Experience drafting and negotiating complex academic center, clinical trial/research, and commercial agreements.JD or equivalent and admission to at least one state bar.Some travel required.

 

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