Sr Director, RA Strategy & Transformation
MedtronicAbout the role
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 Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control while spending less time managing their disease.This role requires an experienced, visionary, and execution-focused regulatory professional to lead high-impact initiatives that transform and elevate the Regulatory Affairs (RA) function to meet the demands of a fast-evolving global regulatory landscape. This individual will play a critical role in defining and executing the RA transformation strategy, driving process improvements, and ensuring regulatory readiness and excellence across the Diabetes Operating Unit. By collaborating with cross-functional teams and executive leadership, this leader will shape the future of Regulatory Affairs to enable business growth, innovation, and compliance.
This is a mission-critical role that partners with executive leadership to build the future of our Regulatory Affairs operations.
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.
Responsibilities may include the following and other duties may be assigned.
Strategic Planning & Regulatory Design
- Develop and refine the long-term Regulatory Affairs strategy, ensuring alignment with the Diabetes Operating Unit’s enterprise goals and global regulatory requirements.
- Identify gaps, inefficiencies, and opportunities in current regulatory processes and systems.
- Collaborate with the senior leadership team to define and prioritize regulatory transformation initiatives, roadmaps, and resource allocation to support business goals.
- Ensure ongoing regulatory compliance and readiness to meet global market demands, including emerging regulations and standards.
- Partner with cross-functional teams to align regulatory strategies with product development, clinical, quality, and operations initiatives.
Transformation Program Leadership
Lead large-scale cross-functional transformation programs within the RA function, from concept to execution.
Define program scope, KPIs, success metrics, and governance structures to track progress and impact.
Drive alignment across business units, geographies, and functions to ensure consistent implementation of regulatory transformation initiatives.
Oversee the implementation of regulatory frameworks, tools, and processes to enhance scalability, efficiency, and compliance.
Process Optimization & Innovation
Introduce and champion continuous improvement practices within RA, leveraging methodologies like Lean, Six Sigma, and Agile to optimize regulatory processes.
Identify and implement technology enablers such as regulatory information management systems (RIMS)
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