Legal Counsel, Fda/Life Sciences Team, Enterprise Legal Regulatory

Careers that Change Lives
Medtronic is seeking an FDA/Life Sciences lawyer as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience of the U.S. Food and Drug Administration (FDA) and how to navigate issues within the agency. The Enterprise Legal Regulatory team supports corporate functions and Medtronic business and regional units around the globe.  As a member of this team, this individual will work with other team members to provide proactive legal advice and counsel managing risk on regulatory, quality and clinical issues involving law and regulations regarding the total product lifecycle of medical devices, including design, clinical data, manufacturing, inspections and marketing and promotion. Key attributes this individual must possess include strong legal and analytical skills and the ability to interact effectively with a variety of individuals in cross-functional roles in the organization.  This role requires a high level of responsiveness to business stakeholders in a large, dynamic and fast-paced environment.
 This position reports to the Legal Director- FDA/Life Sciences, Enterprise Legal Regulatory.
 This position could reside in Minneapolis, MN, Washington D.C., the San Francisco Bay Area, or alternate location to be discussed. A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Work with other attorneys and paralegals on escalated issues relating to advertising and promotional review
• Provide support on a variety of regulatory compliance questions such as those related to product quality, clinical trials, device classification and regulatory submissions, and supply chain
• Facilitate discussion to reach consensus among multi-functional team members regarding resolution of legal and business issues
• Monitor external enforcement in the advertising and promotion area
• Efficiently help support and drive multiple projects to completion
• Partner with Operating Units on advertising and promotion review including Corporate Communications, where applicable, in conducting those reviews
• Provide advice and counsel to Operating Unit and functional clients on a variety of medical device legal regulatory issues and support management of such issues
• Develop and revise policies, procedures, guidance, and tools related to advertising and promotion
• Develop and deliver training content related to advertising and promotion
• Identify, anticipate and help mitigate key legal risks within areas of responsibility