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Legal Director - Products Law Group (Health) The candidate will 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. Will lead a team of attorneys in the Products Legal Group support global business partners across firm that are developing its health technologies, products, and services. 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. Help formulate legal and regulatory strategies and advise on and provide creative solutions to mitigate risks presented by the development of innovative health technologies. Draft, negotiate, and oversee complex agreements facilitating the design, development, and distribution of firmâ€™s health technologies. 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.
Qualification and Experience
The candidate must have JD degree, excellent academic credentials, and admission to one State Bar. Should 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. Prior governmental regulatory experience is preferred. 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 is desired. Transactional experience, and can supervise, draft, and negotiate a variety of complex agreements, including commercial, research, and clinical trial agreements.
Job Number: 114114525
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