1+ months

Senior Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory

Minneapolis, MN 55405
Senior Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory


Minneapolis, Minnesota, United States

Requisition #:


Post Date:

Feb 02, 2021

**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.

**_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 Life**

Responsibilities may include the following and other duties may be assigned.

+ 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.

**Must Have: Minimum Requirements**

+ 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

**Nice to Have**

+ Experience with addressing software quality issues (e.g., software upgrades, product security issues)

+ 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

**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. Lets 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)

Travel is varied (up to 25%) and will be primarily to Medtronic facilities to provide on-site support as needed.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2021-02-04 Expires: 2021-05-13

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Senior Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory

Minneapolis, MN 55405

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