We anticipate the application window for this opening will close on - 29 Sep 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 Coronary and Renal Denervation (CRDN) division is focused on therapies that are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI) while leading the way with the transformational renal denervation therapy, recently approved in the U.S. and which has the potential to be a powerful tool in battling the global hypertension epidemic.

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. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and their experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

This role will be based in Santa Rosa, CA.

The Principal Regulatory Affairs Specialist will support Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. Bringing hands-on expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.,) to support the operating units’ (OU’s) innovative pipeline is key. This individual will support maintaining a strong foundation for future software product development for the Regulatory Function and may also support broader Medtronic enterprise working groups focusing on staying informed and current with global regulation and guidance updates in the digital health space. Additionally, the Principal Regulatory Affairs Specialist 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 Team members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff. 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, and EU MDR Technical Documentation in addition to Change Management assessments. The successful candidate will actively support advertising and promotion activities for commercial products across the CRDN portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise.

Role and Responsibilities

• Works with OU Regulatory Affairs management and staff to build and/ or increase knowledge base in software product development in the digital health space (SaMD, AI, Cybersecurity, etc.).
• Provide tactical and operational support for digital health programs to ensure compliance with applicable regulations and guidance documents.
• Serve as a regulatory liaison for digital health initiatives, ensuring timely execution of deliverables in alignment with broader program goals
• Represents the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.
• Partners with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.
• Leads and influences the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation.
• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes. 
• Acts as a mentor to colleagues within the team and effectively manages an extended team.
• Stays current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.
• Works with functional team members to ensure cl