RegulatoryAffairsSpecialist

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** Job Specific Summary Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic! Reporting to Regulatory Affairs Director, the Regulatory Affairs Specialist will be based in our Glass Tower, Seoul office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing, and legal compliance of a range of our medical devices to control their safety and efficacy mainly for all products. This is a fixed-term individual contributor position for 12 months. **Responsibilities may include the following and other duties may be assigned:** * Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. * Leads or compiles all materials required in submissions, license renewal and annual registrations. * Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. * Monitors and improves tracking / control systems. * Keeps abreast of regulatory procedures and changes. * May direct interaction with regulatory agencies on defined matters. * Recommends strategies for earliest possible approvals of clinical trials applications. **Required Knowledge and Experience:** * Completed Bachelor's degree in any discipline, preferably Bachelor's Degree in Medical/ biological science or equivalent field * At least 2 years of experience in a regulatory affairs role in healthcare industries - Medical devices product licensing experience and / or Korea Good M