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. A Day in the Life We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. The Associate Clinical Quality Specialist will be a part of the MCRS Quality team responsible. This role will support end-to-end business assessment of new and changing (INFORM) regulatory requirements in the Regulatory & Clinical functions. This role will be a remote position based in Colombia. Responsibilities may include the following and other duties may be assigned: - Participate in audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application - Conduct and perform investigations and ensures conformance to regulations and company standard operating procedures. Specifically, as they relate to the Medtronic INFORM process. - Ensure changes in regulations are incorporated into applicable Quality Management System documents - Document audit observations and makes recommendations for corrective and preventive action. - Create and maintain clinical quality assurance databases, reports, and files - Perform quality reviews and tracks corrective and preventive actions until closure - Audit operating systems, processes and procedures - Plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission - Use six-sigma methodology - Support KPI reporting and oversight - Support Quality Planning and Management Review inputs - Provide training on GCP and current regulations for those undertaking clinical studies Required Knowledge and Experience: - Bachelor’s degree - Fluent in English - One year of experience working with quality systems, regulatory affairs, administrative areas or customer service - Knowledge with MS office (Outlook, Word, Excel, PowerPoint) - Knowledge with SAP, Smartsheet, Map Agile, Power BI are advantageous 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 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. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D; lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity