Legal Director - Products Law Group (Health)
Santa Clara Valley (Cupertino), California, United States
Are you passionate about creating powerful health tools and improving the lives of others? Imagine what you could do here. At Apple, we quickly turn new ideas into extraordinary products, services, and customer experiences. Bring your passion and dedication to Apple, and there's no telling what you could accomplish. We are Apple's Products Law Group. We have a new opportunity for a talented lawyer like you to join our team of diverse, creative, and passionate people. Lead 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.
- You have 10+ years of experience providing legal counsel on a broad range of medical device regulatory (in and outside the United States), transactional (including research and clinical trials agreements), and regulatory and compliance matters at a medical device company, respected law firm, or consultancy
- We prefer prior governmental regulatory experience. Familiarity with local, state, federal, and international laws related to licensing of clinicians, digital health tools, healthcare delivery, reimbursement mechanisms and regulations, healthcare conflicts of interest laws, human subjects research, and big data issues are also beneficial
- You can advise and counsel business teams and executive management on complex legal and regulatory matters by drawing upon your significant experience with US and international medical device and diagnostics regulations and other related regulatory issues, including human subjects research, product approval, product marketing, and distribution, as well as HIPAA and similar worldwide privacy laws
- You also have transactional experience, and can supervise, draft, and negotiate a variety of complex agreements, including commercial, research, and clinical trial agreements
- You foster and facilitate teamwork by cultivating relationships, counseling, collaborating, and effectively communicating with teammates and cross-functional partners
- Your communication and analytical skills are strong, and you can assess and articulate complex and nuanced legal risks in “plain English”
- You can navigate and resolve complex issues in creative and effective ways while displaying sharp business insight and analytical skills
- Some travel required
In this role, you will lead a team of attorneys in the Products Legal Group who support global business partners across Apple that are developing its health technologies, products, and services. Your team will collaborate with other legal groups and advise executives and their engineering, marketing, operations, clinical, and regulatory business teams on a variety of matters related to health-related features and products, including product design and development, regulatory compliance, research collaborations and partnerships, and human subjects research. You will also help formulate legal and regulatory strategies and advise on and provide creative solutions to mitigate risks presented by the development of innovative health technologies. You will also draft, negotiate, and oversee complex agreements facilitating the design, development, and distribution of Apple’s health technologies. You will also monitor the progress of healthcare regulations and policies, consult with and respond to inquiries by regulatory agencies, and advise external and internal institutional review boards.
Education & Experience
Requires a JD degree, excellent academic credentials, and admission to at least one state bar.