We anticipate the application window for this opening will close on - 20 Oct 2025

 

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

The Medtronic Structural Heart & Aortic Operating Unit focuses on developing innovative, minimally invasive therapies for treating structural heart diseases, including conditions affecting the heart’s valves and chambers. We are pioneering technologies such as transcatheter aortic and mitral valve replacement, as well as repair solutions that help restore proper heart function and improve patient outcomes. By combining advanced engineering with deep clinical expertise, the Structural Heart team aims to address unmet clinical needs and enhance quality of life for patients worldwide.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

This role will be based in Mounds View, MN.

The Principal Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronic’s Structural Heart & Aortic (SH&A) Operating Unit. The role supports the Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. This role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. The individual will serve as a subject matter expert on regulatory pathways for both hardware and software-based technologies, ensuring compliance and facilitating timely approvals to bring innovative products to market. Additionally, the individual in this role is expected to play a key role in the mentoring of junior team members and to be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs and cross functional members at varying levels within the organization. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation. The successful candidate will also actively support advertising and promotion activities for commercial products across the Structural Heart & Aortic (SH&A) portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise. 

Role and Responsibilities 

• Develop and execute global regulatory strategies for new product development and introduction, including software-based solutions and hardware. 

• Advise cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR, NMPA (China), PMDA (Japan), and TGA (Australia). 

• Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU Technical Files, EU Design Dossiers, China NMPA registration, Japan PMDA Shonin, Australia TGA conformity assessments). 

• Lead regulatory risk assessments during product design and development, providing solutions to minimize approval delays.