Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you’re collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team. Be part of a company that’s a trusted leader in breast cancer diagnostics and support products you can feel passionate about! Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The RAQA Specialist for Mammotome is responsible for participation in global regulatory and quality activities, including regulatory submissions, renewals, license inventory, product and process change assessments, labeling review, and general regulatory documentation requests. Additionally, they will have responsibilities related to Quality functions such as QMS maintenance for the Korea organization, post-market activities including complaint handling and regulatory reporting, and communication with regulators. The Quality & Regulatory Specialist (Korea) will also participate on New Product Development (NPD) teams to develop and execute a regulatory strategy for new product launches. This position is part of the Global Regulatory Team located in Seoul, South Korea and will be onsite. At Mammotome, our passion is driving innovative technologies that create efficiencies, while never forgetting that at the heart of every breast cancer journey is a patient. You will be a part of the Mammotome Regulatory Team and report to the Mammotome Director, Regulatory Affairs and is responsible for quality and regulatory affairs functions in Korea to achieve business growth and drive commercial execution. If you thrive in a high-responsibility, self-driven and multifunctional role and want to work to build a world-class regulatory organization—read on. In this role, you will have the opportunity to: + Take responsibility for Mammotome Regulatory Korea strategy and registrations including MFDS and Quality Management System solutions; regulatory strategy development, product change evaluation and submission; Regulatory Intelligence for the Korea market; evaluates product requirements for compliance to Korean requirements. + Manage Korea QMS requirements to ensure compliance to standards and regulations, including Quality Manual, and takes on Quality-related duties especially around post-market data collection, non-conforming product, complaint reporting, and CAPA processes and procedures. + Cultivate good relationships with regulators, in-country business representatives, testing and inspection facilities, and the global Regulatory and Quality team to ensure best in class Regulatory and Quality outcomes. + Evaluates local and global procedures to ensure compliance to Korean regulations and maximum efficacy and efficiency. + Maintain Quality and Regulatory documentation in Korea compliant with applicable Quality and Regulatory standards and regulations in Korea. The essential requirements of the job include: + Excellent verbal and written communication skills in both Korean and English, in addition to software familiarity with Microsoft Office suite. + Minimum of 3 years experience in Regulatory, Quality, or engineering experience in the medical device field, and a Bachelors degree, preferably in a scientific field. + Complete and detailed understanding of Korean Regulatory and Quality medical device compliance requirements. + Successful track record of working in a Global Matrix/Collaborative environment. + Ability to work independently while maintaining excellent communication with supervisor and team. Travel, Motor Vehicle Record & Physical/Environment Requirements: + Travel planning in-line with scheduling. Expected up to 15% of the time; global travel is required occasionally. + Typical work-related travel 1-5 days, may extend over the weekend occasionally for international travel. + Physical demands: While performing the duties of this job, the employee is occasionally required to walk, sit, stand, use hand to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance, stoop, bend, talk and hear. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.