Sr Director, RA Strategy & Transformation

Posted:
9/19/2025, 6:59:28 AM

Location(s):
California, United States ⋅ Los Angeles, California, United States

Experience Level(s):
Expert or higher ⋅ Senior

Field(s):
Business & Strategy

We anticipate the application window for this opening will close on - 22 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 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), automation, and advanced analytics to enhance productivity and decision-making. 

  • Evaluate current regulatory processes and implement scalable, sustainable improvements to support product lifecycle management and global submissions. 

Change Management & Culture Building 

  • Develop and lead change management strategies to drive adoption of new regulatory processes, systems, and operating models. 

  • Foster a culture of excellence, innovation, and collaboration within the RA function. 

  • Build organizational capabilities to adapt to evolving regulatory requirements and industry trends. 

Executive Collaboration & Reporting 

  • Provide regular updates to the VP of Regulatory Affairs and senior executives on strategic initiative progress, risks, and ROI. 

  • Serve as a key advisor and thought partner in regulatory planning, decision-making, and future-state design. 

  • Build dashboards and executive presentations to communicate regulatory transformation progress and strategic impact. 

 

Must Have: Minimum Requirements

  • Bachelor's degree and 15+ years of experience with 10+ years managerial experience
  • Or, Master's degree and 13+ years of experience with 10+ years managerial experience

Nice To Have

  • Proven experience in Regulatory Affairs leadership, with a strong track record in driving transformational initiatives. 

  • Comprehensive understanding of global regulatory requirements and standards (e.g., FDA, ISO, MDR, IVDR, etc.). 

  • Expertise in process optimization, change management, and leveraging technology to drive efficiency in regulatory systems. 

  • Strong collaboration and leadership skills, with the ability to influence and align cross-functional teams. 

This role is pivotal in ensuring Medtronic’s Diabetes Operating Unit remains a leader in regulatory excellence, enabling innovation while maintaining compliance and patient safety. 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$221,600.00 - $332,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.