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Senior Staff Counsel The candidate will manage day-to-day legal affairs of certain firm international medical device companies under general supervision of Chief Healthcare Counsel and in coordination with other firm legal departments located outside the U.S.. Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to medical device and healthcare companies, such as Physician Payment Sunshine Act and Anti-Kickback. Directly draft, review and negotiate variety of commercial contracts, including customer, distributor and vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among others. Also, work with outside counsel on a regular basis to review and handle large volume of contracts, to ensure agreements meet management/corporate objectives. Perform general corporate and pre-litigation/litigation work to minimize risks and maximize legal rights. Prepare and maintain corporate records for accuracy and thoroughness. Participate in the development and structuring of new business ventures. Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies. Provide training to HLUS and its subsidiary companies on substantive legal topics, including FDA regulations and other regulations specific to medical device and other healthcare companies, such as Physician Payment Sunshine Act and Anti-Kickback. Must have 6-8 years of relevant experience in a corporate law firm and /or in-house legal department, preferably for international medical device companies. Must have College degree and juris doctorate degree from accredited law school. Admitted to NY Bar is required. Academic honors is preferred. Solid commercial contract background with extensive drafting experience is needed. Experience managing outside counsel and/or legal staff is must. In-depth knowledge of FDA regulations and other regulations specifically applicable to the medical device industry is essential. In depth knowledge of legal practices, including regulations affecting international medical device companies and the healthcare industry generally is required. Strong contract drafting and negotiation skills is essential.
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