Title: Legal Counsel
Company: Samsung Research America (SRA)
Location: Mountain View, CA
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
Samsung is committed to encouraging a diverse workplace and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.
If you have a disability or special need that requires accommodation, please let us know.