Regulatory Operations Specialist

About Medtronic

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.

Job Summary

Sitting in the Diabetes Regulatory Operations Team, the Regulatory Operations Specialist will be a key member managing regulatory data attributes, distribution control mechanisms, and preparation and publishing of submissions. 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.

Key Responsibilities

• Develop key partnerships with stakeholders across functional groups, and regions to align on harmonized processes
• Manage publishing activities for multiple projects
• Manage UDI Database including uploading of data to relevant regulatory bodies
• Manage FURLs Database including uploading of data
• Support Product Blocks and Product Release Activities

Requirements

• Minimum 2 years of experience with a Bachelor’s Degree or advanced degree
• Strong project management skills
• Proven ability to work globally
• Self-motivated, entrepreneurial, independent, driven individual to meet objectives
• Excellent written and oral communication skills
• Ability to think strategically and execute methodically
• Ability to quickly learn new computer technology software packages with minimal training
• Ability to work effectively within a matrix environment
• Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
• Ability to influence cross-functional teams without formal authority
• Strong attention to detail and an ability to deal with ambiguity

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.