Senior Regulatory Operations Specialist
About this role
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.
#BetterDaysStartNow
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.
Originally posted on Himalayas
