At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Medtronic Diabetes is seeking an FDA/Regulatory Law attorney with knowledge and experience of U.S. Food and Drug Administration (FDA) and global regulatory laws affecting medical device manufacturers. The role will support several of the company’s corporate functions, including Quality, Clinical, and Regulatory, and our regional partners around the globe. This individual will provide proactive legal advice and counsel managing risk on issues involving law and regulations regarding the total product lifecycle of medical devices, including design, clinical data, manufacturing, inspections, post market surveillance, and marketing and promotion on a global basis. 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 is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

This will be a remote role and will need to reside in the US.

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

• • Acting as strategic legal/business partner for the MiniMed business in substantive legal areas on issues of global government regulation and enforcement.   

  • Partnering with the business in conducting reviews of advertising and promotion collateral. 

  • Developing and revising policies, procedures, guidance, and tools related to advertising and promotion. 

  • Developing and delivering training content related to areas of FDA law as well as global regulatory laws and regulations. 

  • Supporting business leaders and the 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 and other regulatory requirements.   

  • Supporting leadership and the Quality function in drafting audit and inspection responses, including responses to FDA Form 483s and Warning Letters, if needed. 

  • Providing counsel to the Quality function on FDA Quality System Regulation requirements and supporting the development of appropriate Corrective and Preventive Actions (CAPAs). 

  • Partnering with the legal team and the Quality function to develop and review policies, procedures, guidance documents, and tools. 

  • Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to regulatory or quality matters.  

  • Delivering sophisticated legal regulatory expertise on quality and advertising and promotion issues; an understanding of regulatory trends, regulations, guidance and policies; and experienced perspective on how to calibrate risk and respond to related issues. 

  • Providi