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Years of Experience
Date Last Verified
Senior Counsel Regulatory Law, Medical Device The candidate will be a member of the Global Regulatory Legal Team and provide specialized legal support for assigned companies and products in the Medical Device Sector. Be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, quality and other post-market requirements, with a primary focus on medical devices. Provide legal counsel on health care laws, including the Federal Anti-Kickback Statute, and related health care legal obligations and on legal requirements related to privacy and data protection. Provide advice on marketing and sales activities and programs, including review of advertising and promotional materials and competitive advertising matters, advise on product life cycle management strategies, and will work with clients to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders. Provide and coordinate legal support in these fields, be a member of the relevant functional teams supporting assigned companies and interact with business and Law Department management on these matters. Engage in initiatives with trade associations and policy teams related to regulatory issues. Work closely with other Law Department colleagues to provide consistent and efficient legal support to company.
Qualification and Experience
A Juris Doctor Degree and admission to (and current good standing with) the Bar of at least one U.S. state or the District of Columbia are required. 5 years of experience advising clients on FDA regulatory matters is required, a focus on medical device products is strongly preferred. Experience in the legal review of promotional materials, and in counseling on other aspects of regulatory strategy for product submissions and product lifecycle, including quality/compliance counseling in areas such as Good Manufacturing Practices, Quality Systems Regulations, Good Clinical Practices, field action decision-making, and mandatory reporting obligations is required. Experience in advising on health care compliance obligations, including the U.S. Health Care Fraud and Abuse Laws is required. Experience in a law firm supporting clients in the life sciences industry on regulatory matters or in a regulatory agency, such as the U.S. F.D.A., is strongly preferred. Some in-house counsel experience with a medical products company and international health law experience, including familiarity with regulatory regimes in other jurisdictions, is also preferred. Must have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work independently and to collaborate on teams.
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