Medtronic is seeking an FDA/Life Sciences lawyer as a member of the Enterprise Legal Regulatory 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 and quality 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 and functional 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
Responsibilities for this position include:
Acting as strategic legal/business partner for the Medtronic Operating Units (OUs) businesses in substantive legal areas on issues of government regulation and enforcement while serving on a strong Corporate-level team of in-house FDA/Life Science lawyers and technical professionals.
Support business OUs and Quality function in developing and executing Issue Impact Assessments and Field Corrective Action Plans with respect to potential product quality issues and evaluating those issues for reportability under FDA regulatory requirements.
Support OUs and Quality function in drafting audit and inspection responses, including responses to FDA Form 483s and Warning Letters.
Provide counsel to OUs and Quality function on FDA Quality System Regulation requirements and support OUs and Quality function in developing appropriate Corrective and Preventive Actions (CAPAs).
Partner with the Corporate Quality function to develop and review policies, procedures, guidance documents, and tools.
Provide support to one or more Quality Sub-Councils.
Develop and deliver training content related to areas of FDA law and regulation.
Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to quality matters.
Identifying and driving mitigation of risks that cross Medtronic businesses and facilitating information sharing across and among Medtronic businesses.
Deliver sophisticated legal regulatory expertise on quality issues; an understanding of regulator trends, regulations, guidance and policies; and experienced perspective on how to calibrate risk and respond to quality issues.
Provide strong business-oriented solutions combined with deep quality expertise.
MINIMUM REQUIREMENTS: MUST HAVES
Juris Doctor from nationally recognized Law School
Licensed to practice law in at least one state or the District of Columbia
8+ years of legal experience in FDA/life sciences regulatory law
Prior work experience at, or direct engagement with, the FDA
Ability to establish credibility and develop strong working relationships with clients
Capable of and experienced in effectively working in groups and with senior management
An understanding of business objectives, strategies and relevant tactics
Seasoned professional with good professional judgment
Exceptional oral and written communications skills
Strong team skills
Internal Number: 210002G8
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.