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.
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
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.
MUST HAVE: MINIMUM REQUIREMENTS
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
NICE TO HAVE
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
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
Internal Number: 210002GG
About Medtronic
At Medtronic, we believe in the power of medical technology to improve lives. Seven decades ago, our co-founder invented the battery-powered pacemaker. Today, we are among the largest medical device companies in the world. With operations in 150 countries, our products treat 70 health conditions and include cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Our therapies help 72 million people a year and support our Mission to alleviate pain, restore health, and extend life.
Our people make it possible. We value diverse perspectives and encourage our 90,000+ employees to be themselves. We hold each other accountable, act with integrity, and make quality our highest priority.
We are privileged to be part of the communities where we live and work. We are committed to giving back and reducing our impact on the environment.
Let's take healthcare Further, Together.
