Medical device company seeks Regulatory Counsel to support sales and marketing activities. Position will be the primary attorney handling these matters in the legal department.
Duties:
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Facilitate the business objectives of the company by providing practical, timely and effective legal support, while minimizing potential legal risks
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Provide high quality guidance and support to the company’s regulatory and quality assurance teams and business units on healthcare and medical device regulatory matters
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Advertising and promotion
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Healthcare fraud and abuse
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Antitrust (such as tying arranagements)
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Implement policies and procedures
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Coordinate cross functional, regional teams
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Oversee compliance monitoring (in partnership with the Compliance Department)
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Assess risks and establish metrics for effectiveness
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Work in close cooperation with Compliance Department, including participation in investigations when required
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Develop a thorough understanding of and familiarity with: the company’s business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel
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Identify training needs and assist in development and presentation of training and education regarding regulatory requirements and developments
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Perform special assignments or projects if necessary
Required:
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Licensed and admitted to practice law in good standing in at least one U.S. state
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At least 7 years of experience in private practice, in-house counsel and/or government (FDA)
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Demonstrated experience in FDA regulatory law
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Experience with US device marketing, advertising and promotion regulations
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Ability to analyze and interpret efficacy and safety data
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Decision-making ability and experience
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Problem solver—able to find practical solutions and provide practical guidance
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Accountable and hands-on, self-starter, results oriented
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Desire to understand products and business
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Able to gain the trust of and form solid relationships with various business clients and Legal Department colleagues
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Able to manage multiple high-priority projects simultaneously
Desired Experience:
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At least 2-3 years as in-house counsel in medical device or pharmaceutical industry
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General understanding of medical device regulation outside of the U.S.
