Associate Regulatory Operations Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the LifeThe Associate Regulatory Operations Specialist – Product Release, will support the timely and compliant release of medical devices while collaborating with global stakeholders across Latin America, Europe, and Asia. This role focuses on Product Release operations, regulatory process execution, compliance activities, process improvements, and cross-functional collaboration within a highly regulated environment. This is a fully remote role based in Colombia.
Responsibilities may include the following and other duties may be assigned:
Execute day-to-day Product Release activities in SAP, including activities within the Global Trade System (GTS) module, supporting daily regulatory operations
Review, analyze, and exchange information required to support Product Release activities and team objectives
Collaborate with Regulatory Affairs, Supply Chain, and Customer Care teams to support operational and strategic objectives
Support Corrective and Preventive Action (CAPA) activities, including information gathering, investigation support, and documentation
Identify opportunities for harmonization, efficiency improvements, and continuous process improvement initiatives
Support global transformation projects related to Product Distribution Control
Required Knowledge and Experience:
Bachelor’s degree in Biomedical Engineering, Bioengineering, Pharmaceutical Chemistry, or a related field.
Fluent English required, both written and spoken.
Ability to communicate effectively and collaborate with stakeholders across Latin America, Europe, and Asia
Strong communication, organization, time management, and teamwork skills
Quality-focused mindset with strong attention to detail
Ability to work effectively in a dynamic, highly regulated, and global environment
Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint
Experience in the medical device industry or other regulated environments is preferred
Experience with SAP, particularly exposure to the GTS module, is preferred
Previous exposure to compliance-driven environments, CAPA activities, or process improvement initiatives is preferred
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.
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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.
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This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).