Senior 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

• Partner with Operating Units on advertising and promotion review including Corporate Communications, where applicable, in conducting those reviews
• Monitor external enforcement in the advertising and promotion area
• Develop and revise policies, procedures, guidance, and tools related to advertising and promotion
• Develop and deliver training content related to advertising and promotion
• Work with group of paralegals on escalated issues relating to advertising and promotional review
• Provide support on review of clinical trial protocols, external research program issues, and other clinical/quality issues
• Identify, anticipate and help mitigate key legal risks within areas of responsibility
• 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
• Facilitate discussion to reach consensus among multi-functional team members regarding resolution of legal and business issues
• Efficiently help support and drive multiple projects to completion

MUST HAVE: MINIMUM REQUIREMENTS

• Juris Doctor from nationally recognized Law School
• 2+ years of legal experience in FDA and advertising and promotion law
• Licensed to practice law in at least one state or the District of Columbia

NICE TO HAVE

• Specialized experienced with social media advertising and/or direct-to-consumer advertising
• Experience supporting or drafting FDA regulatory submissions
• Experience counseling on clinical trial compliance, investigational device exemptions, and/or ClinicalTrials.gov registration and reporting requirements
• Prior work experience at, or direct engagement with, the FDA
• Direct client contact
• Exceptional advocacy and negotiating skills
• Medical device industry experience
• Excellent written and verbal communication skills
• Demonstrated strong analytical thinking ability
• Flexibility, adaptability, and pragmatism
• Superior common sense and judgment
• Excellent analytical risk identification, evaluation, and management skills
• Capable of inspiring trust and confidence of client groups

PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job

• 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.
• 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.
• Some travel required (less than 10%)