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Legal Director-FDA/Life Sciences Law

Company: Medtronic GmbH
Location: Minneapolis
Posted on: February 25, 2021

Job 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. A DAY IN THE LIFE: 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. MUST HAVE:

  • Juris Doctor from nationally recognized Law School
  • Licensed to practice law in at least one state or the District of Columbia
  • 10+ years of professional experience
  • 6+ years of concentrated legal experience in Food and Drug Law, specifically FDA regulation, guidance and policy, submissions, advertising and promotion, off label and direct-to consumer promotion, enforcement issues SPECIALIZED KNOWLEDGE REQUIRED:
    • Experience in regulation of social media, direct-to-consumer advertising, case law and FDA and FTC enforcement on advertising and promotion issues NICE TO HAVE:
      • Experience with digital health, artificial intelligence, machine learning, and/or software as a medical device issues.
      • Strong leadership, management and team skills.
      • Ability to establish credibility and develop strong working relationships with clients and regulators.
      • Capable of and experienced in effectively working in groups and with senior management.
      • Capable of leading a team to leverage strengths across businesses and geographies.
      • An understanding of business objectives, strategies and relevant tactics.
      • Seasoned professional with good analytical skills and professional judgment.
      • Exceptional oral and written communications skills. About Medtronic
        Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

        We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

        Physical Job Requirements

        The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Minneapolis , Legal Director-FDA/Life Sciences Law, Legal , Minneapolis, Minnesota

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