Assoc Regulatory Oper Spec

Job description

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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefits & CompensationMedtronic 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).