Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory
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 Senior Legal Director - FDA/Life Sciences, Enterprise Legal Regulatory.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
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 LifeResponsibilities may include the following and other duties may be assigned.
- Identify, anticipate and help mitigate key legal risks within areas of responsibility.
- Partner with the Clinical and Regulatory functions to develop and review policies, procedures, guidance documents, and tools.
- Coordinate with the Regulatory and Clinical functions to analyze the potential impact of new and changing regulations.
- Provide counsel to Operating Units (OUs) and the Clinical function on the execution of clinical trials in compliance with FDA legal and regulatory requirements.
- Provide counsel to OUs and the Clinical function on clinical trial data transparency requirements and initiatives (e.g., ClinicalTrials.gov requirements).
- Support OUs and the Clinical and Quality functions in drafting audit and inspection responses, including responses to Bioresearch Monitoring FDA Form 483s and Warning Letters.
- Deliver sophisticated legal regulatory expertise on clinical and regulatory issues; an understanding of regulator trends, regulations, guidance and policies; and experienced perspective on how to calibrate risk and respond to clinical and regulatory issues.
- Provide strong business-oriented solutions combined with deep clinical/regulatory expertise.
- On behalf of the ELR Center of Expertise, serve as a strategic Legal partner to one or more Operating Units.
- 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.
- Juris Doctor from nationally recognized Law School
- 5+ years of legal experience in FDA law
- Licensed to practice law in at least one state or the District of Columbia
- Experience supporting or drafting FDA regulatory submissions
- Experience counseling on clinical trial compliance, investigational device exemptions, and/or ClinicalTrials.gov registration and reporting requirements
- Experience with digital health, artificial intelligence, machine learning, and/or software as a medical device issue
- 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
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)
10% travel.
