Senior Regulatory Operations Specialist

MiniMed; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible benefits

Remote-friendly

Job summary

MiniMed is seeking a Senior Regulatory Operations Specialist to help bring life-changing diabetes technologies to patients worldwide. You will lead GTS license activities, maintain licenses, and support regulatory management systems in a fully remote, global environment.

The role requires a bachelor’s degree with 2+ years in regulatory operations (or an advanced degree with 0 years). You will collaborate with cross-functional teams across regions, drive process improvements, and ensure

Qualifications

• Bachelor’s degree plus at least 2 years of regulatory operations experience, or an advanced degree with 0 years.
• Experience with regulatory licensing and GTS processes is strongly preferred.
• Experience with medical devices or regulated industries is a plus.
• Strong organizational and problem-solving skills and ability to handle multiple tasks.

Responsibilities

• Manage GTS license activities, including license maintenance and resolution of license blocks.
• Coordinate enterprise regulatory management systems, including user training and plan development.
• Monitor process efficiency and vendor performance; drive continuous improvement.
• Collaborate with global teams to support regulatory licensing across regions.
• Identify opportunities to improve processes, systems and ways of working.
• Work independently in a fully remote environment across time zones.

Skills

Regulatory operations

GTS licensing

SAP knowledge

Regulatory systems

Global collaboration

Process improvement

Time zone coordination

Education

Bachelor’s degree

Tools

SAP

Regulatory management system

Job description

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You’ll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

Help bring life-changing diabetes technologies to patients around the world. As a Senior Regulatory Operations Specialist at MiniMed, you’ll play a pivotal role in supporting innovative medical devices and software through complex regulatory and licensing processes, helping turn breakthrough ideas into real-world impact.

Working across global teams and regulatory functions, you’ll be responsible for GTS license activities and regulatory management systems, ensuring licenses are maintained effectively, issues are resolved, and processes continue to evolve. This is an opportunity to make a meaningful contribution to diabetes care while working in a collaborative, global environment.

The role is fully remote.

Responsibilities may include the following, and other duties may be assigned:

• Responsible for GTS license activities, including license maintenance, creation, and resolution of license blocks.
• Support activities related to enterprise-wide regulatory management systems, including system coordination, user training, development and implementation of plans, and providing input into system design and improvements.
• Monitor and support process efficiency and continuous improvement, including evaluating the effectiveness of external vendors.
• Collaborate with global teams and stakeholders to support regulatory licensing activities across different regions.
• Identify opportunities to improve processes, systems, and ways of working to increase efficiency and effectiveness.
• Work independently in a fully remote environment while collaborating with colleagues and stakeholders across different time zones.

Required Knowledge and Experience:

• Practical knowledge and demonstrated competence in the relevant job area, typically gained through advanced education combined with professional experience.
• Bachelor’s degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
• Previous experience in a similar regulatory operations, licensing, or GTS-related role is strongly preferred, enabling the successful candidate to become productive relatively quickly.
• Basic knowledge of SAP is preferred. Experience with SAP is an advantage, but experience with a similar enterprise or regulatory management system may also be considered.
• Experience working with medical devices or another highly regulated industry is preferred.
• Strong organizational and problem-solving skills, with the ability to manage multiple activities and resolve issues effectively.

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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.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we’ve been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we’re dedicated to continuing to support our customers through every step of their journey - meeting them where and how they need it.