Legal Counsel IV - FDA / Medical Device
The candidate will manage legal business matters pertaining to the organization. Will provide a variety of general corporate and commercial legal services to a number of in-house clients. Act as advisor on legal issues involving the organization's government and regulatory compliance. Review legal data and advises organization on appropriate legal action to be taken. Coordinate legal matters handled by outside counsel.
The candidate should have a J.D. degree from ABA accredited law school and Bar membership in one state in the United States. Must have 5-8 years of experience, preferably with 2-3 years of in-house experience. Experience of advising on and working knowledge of healthcare and medical device laws and regulations, including FDA, Anti-Kickback/Anti-Fraud compliance, STARK laws, HIPAA, advertising and promotional labeling, clinical trials (both investigator initiated and vendor initiated) and other similar laws and regulations applicable to therapeutic medical devices needed. General understanding of principles relating to medical device regulations of other countries would be an asset. General understanding of laws and regulations relating to patient/data privacy, anti-corruption, and anti-competition needed. Strong commercial transactions experience essential. Prior experience in a medical device company would be a big plus. Capability in other languages is also a big plus. Experience in general corporate matters, including corporate organization, securities compliance, drafting transactional documents, license agreements, employment law, immigration law, regulatory matters, risk management asset-backed financing, and contract management. Experience in trade secrets, advertising law, registration and other resolutions specific to the computer and technology industry as well as SEC reporting.
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