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Regulatory Operations Specialist I – Structural Heart
hace 3 meses
.Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.Structural Heart Business Mission: why we existOur business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.The Opportunity We are seeking a Regulatory Operations Specialist I for our St. Paul, MN Structural Heart team to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities.What You'll Work On Responsible for following SOPs for managing regulatory documents and records in Global Product Registration (GPR) system and overall regulatory operation activities.Ensure communications convey all necessary detail and adhere to applicable regulatory standards.Have a basic understanding of Structural Heart product families. Organize product information for internal procedures, quality plans and audit needs.Understand Windchill and other business systems for change control, documentation control and other Regulatory Affairs related interactions with these systems.Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, global in-country affiliates and IT.Monthly collection and analysis of data for key performance indicators (KPIs) for Regulatory department. Assist drafting departmental monthly reports and presentations.Participate in Regulatory departmental process improvement initiatives, including CAPA projects. Support process development and drafting procedures. Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures and task assignments
