Division Counsel, Regulatory and Compliance
Major, Lindsey & Africa - Santa Clara, CA

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Abbott Laboratories (†Abbott† or †Company†) has retained Major, Lindsey & Africa on an exclusive basis to conduct a search for a Division Counsel, Regulatory and Compliance (†Counsel†) to be located in its Vascular Division in Santa Clara, California. Division Counsel, Regulatory and Compliance Overview: The Division Counsel, Regulatory and Compliance, will report to the Divisional Vice President and Associate General Counsel. This position will be primarily responsible for counseling on complex regulatory issues such as FDA laws, regulations, and guidance documents relating to medical device advertising and promotion, scientific exchange, and lifecycle management. The position will also be responsible for reviewing key business strategies of multiple functions, including marketing, commercial operations, and medical science; advising on adverse event handling; and regulatory agency strategy on inspectional and product safety issues, communications, and product quality issues. Responsibilities also include counseling on fraud and abuse issues relating to medical device sales and marketing activities, including the Anti-kickback Statute and False Claims Act, as well as contract and pricing strategies such as discounts, rebates, and bundling methodologies. Location: This position is located in Santa Clara, California.Company: With approximately $22 billion in net sales, Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. In 2014, it was honored by Fortune Magazine as one of the world†s most admired companies.Experience: 10+ years of experience and demonstrated expertise in providing legal counsel on FDA regulatory and compliance issues relating to medical devices and/or pharmaceuticals with a major corporation or law firm. Must have demonstrated ability to perform successfully in cross-functional teams, with the ability to lead, influence, and mentor both attorneys and business partners. Must have ability to handle multiple projects in a fast-paced environment and exercise sound commercial and legal judgment. In addition to top-notch legal skills, must have excellent interpersonal, communication and organizational skills. Prior government experience is also beneficial.Relos: Yes. This is a national search. Abbott will relocate for the right candidate.
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