Legal Director - FDA/Life Sciences Law

POSITION DESCRIPTION:

The FDA / Life Sciences Legal Director will have leadership responsibility for a corporate shared-service team of a lawyer and senior paralegals with deep substantive expertise in advertising/promotion law. The Legal Director will be part of the FDA / Life Sciences team with knowledge and experience of the U.S. Food and Drug Administration (FDA).  The FDA / Life Sciences team supports corporate functions and Medtronic business and regional units around the globe.  In the Director role, this individual will work with other team members to provide proactive legal advice and counsel managing risk on advertising and promotion.  In addition, this individual will keep current and provide subject matter expertise on innovative legal regulatory approaches for digital health technologies, and other emerging regulation for artificial intelligence and machine learning in software as a medical device.  Team members work across business units and geographies resulting in a unique ability to 1) identify common and conflicting legal issues and positions and 2) contribute to high-level policy decision-making. This role requires a high level of responsiveness to business and functional stakeholders in a large, dynamic and fast-paced environment.

The FDA / Life Sciences Legal Director will report to the Senior Legal Director of the FDA / Life Sciences Center of Expertise (COE) team.  

This position could reside in Minneapolis, MN, Washington D.C., the San Francisco Bay Area, or alternate location to be discussed.

POSITION RESPONSIBILITIES:

 Responsibilities for this position include:

• Lead a team of a lawyer and paralegals to oversee and review promotional materials for business Operating Units.
• Provide deep expertise on direct-to-consumer advertising, social media, off-label promotion risk, digital health, and software as a medical device issues to Operating Units, Compliance and other relevant functions.
• Provide strategic direction to COE Senior Director and VP on all issues regarding advertising and promotion.
• Lead content development and counsel on procedures and risk mitigation practices associated with promotion and advertising.
• Drive change management and operating mechanisms for team to provide cost efficient, risk-calibrated review of Operating Units promotional materials, including product brochures and Medical Education and training; implement method for prompt escalation of high-risk issues.
• Monitor the external regulatory and enforcement environment to identify risks/trends in areas of promotion and advertising, digital health, and artificial intelligence/software as a medical device issues.
• Manage and provide leadership for direct reports, including coaching, development and evaluation of employee performance.
• Partner with Medtronic Regulatory Function to provide legal support and guidance, including developing policies, procedures, legal guidance documents, tools and training materials related to advertising and promotion.
• Provide legal support of compliance investigations for the Office of Ethics and Compliance involving advertising and promotion issues.
• Build and maintain relationships with key regulators and industry leaders on advertising, promotion and digital health issues.
• Provide and work with fellow ELR advertising experts in supporting a think tank for counseling, training and providing strategic guidance for Medtronic businesses in FDA advertising and promotion law.
• On behalf of the ELR COE, serve as a strategic Legal partner to one or more Operating Units.