Senior Principal 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 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.