Legal Counsel - FDA/Life Sciences Team

Medtronic•Minneapolis, MN

1d•$96,000 - $144,000•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is seeking an FDA/Life Sciences lawyer as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements for regulated industries. The ELR team supports corporate functions and Medtronic business and regional units around the globe. As a member of this team, this individual will conduct first line legal review of advertising and promotional materials for medical devices. They will also work with other ELR team members to provide proactive legal advice and risk management counsel related to the promotion of medical devices. This individual must possess strong legal and analytical skills. They must also have the ability to interact effectively with a variety of individuals in cross-functional roles in a large and complex organization. This role requires a high level of responsiveness to business stakeholders in a dynamic and fast-paced environment. This position reports to the Legal Director- Quality, Clinical, and Regulatory Compliance, FDA/Life Sciences, Enterprise Legal Regulatory. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This is an onsite position that could reside in Minneapolis, MN, Washington, D.C. or Irvine, CA.

Requirements

Juris Doctor from nationally recognized Law School
Licensed to practice law in at least one state or the District of Columbia

Nice To Haves

Experience in FDA law and advertising and promotion legal requirements
2+ years of experience focused on advertising and promotion work in a regulated industry e.g., medical device, drug, cosmetics, food or beverage
Medical device or pharmaceutical industry experience
Experience with social media advertising and/or direct-to-consumer advertising
Experience working in the Veeva PromoMats advertising and promotion software platform.
Exceptional attention to detail and the ability to manage multiple projects with competing deadlines
Ability to navigate a large organization and communicate effectively with cross-functional stakeholders
Strong organizational skills and comfort working independently with minimal supervision
Direct client contact
Exceptional advocacy and negotiating skills
Excellent written and verbal communication skills
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
Prior work experience at, or direct engagement with, the FDA
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Partner with cross-functional team members in business units to review and approve advertising and promotion materials
Identify, anticipate and help mitigate key legal risks within the business unit related to advertising and promotional materials
Provide advice and counsel to business and functional clients on a variety of medical device legal regulatory issues, collaborating to identify and help employ business-oriented solutions
Work with the business and ELR attorneys on escalated issues relating to advertising and promotional review
Provide support to the Senior Legal Program Manager to drive completion of advertising and promotion process updates, review optimization, and other special projects for the legal function
Support the development and revisions to global policies, procedures, guidance, and tools related to advertising and promotion
Support the development and delivery of training content related to advertising and promotion
Monitor external enforcement in the advertising and promotion area
Identify, anticipate and help mitigate key legal risks within areas of responsibility
Efficiently help support and drive multiple projects to completion

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)