General Commercial/Contracts Law, Healthcare, Multinational Business
In this role, you will support SRA business leaders who are developing its technologies, products, and services by collaborating with and advising executives and their engineering, clinical, and regulatory business teams on a variety of matters, including health-related features and products, 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 technologies; while drafting, negotiating, and overseeing complex agreements that facilitate the design, development, and distribution of various technologies. You will also monitor the progress of regulations and policies, consult with and respond to inquiries by regulatory agencies.
Draft and advise on a wide range of contracts, including clinical trial agreements, business associate agreements, research agreements, license agreements, service agreements and statements of work, privacy and data security agreements, and confidentiality agreements.
Perform legal analysis and make recommendations on legal, contractual, risk, and compliance issues.
Conduct legal and non-legal research, fact-finding and due diligence projects.
Perform efficient and timely delivery of legal advice; anticipates, mitigates, and advises regarding any potential legal problems across corporate groups, client engagements, and third-party relationships.
Serve as liaison for legal matters among in-house counsel, executive leadership, management, outside legal counsel and other experts.
Manage outside counsel when retained to address issues requiring special expertise and ensure timely and cost-effective delivery of legal representation.
Other duties as assigned.
5+ years of experience in a leading law firm or in-house role providing legal counsel on a broad range of medical device regulatory in the United States, transactional (including research and clinical trials agreements), and regulatory and compliance matters at a medical device company or respected law firm
Experience with transactions and with drafting and negotiating a variety of complex agreements, including commercial, research, and clinical trial agreements
Familiarity with local, state, and federal laws and regulations related to licensing of clinicians, digital health tools, human subjects research, privacy and data issues
Ability to advise and counsel business teams and executive management on complex legal and regulatory matters by drawing upon your 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
Capable of fostering and facilitating teamwork by cultivating relationships, counseling, collaborating, and effectively communicating with teammates and cross-functional partners
Strong communication and analytical skills
Ability to navigate and resolve complex issues in creative and effective ways while displaying sharp business insight and analytical skills
Good judgment, including good business judgment
Must be admitted to the State Bar of California and in good standing
Must have Juris Doctor from an accredited law school
Prior experience in a healthcare setting
International company experience a plus
Bilingual English & Korean
About Samsung Research America
At Samsung, we follow a simple business philosophy: to devote our talent and technology to creating superior products and services that contribute to a better global society. Every day, our people bring this philosophy to life. Our leaders search for the brightest talent from around the world and give them the resources they need to be the best at what they do. We have the power to enrich lives. And that's what making a better global society is all about.