Careers that Change Lives

　　Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Should you be looking for the opportunity to be on the cutting edge of medical devices regulatory affairs, apply now and we’d be happy to hear from you!

　　The Sr 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. You will be an experienced Regulatory Affairs Specialist, having had min 6 year’s relevant experience preferably within the medical devices industry. It is a wonderful opportunity over time, to take your monitoring career towards your career growth in medical technology and device research.

　　At Medtronic, you will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

　　A Day in the Life

　　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

　　Direct communication with global stakeholders

　　Work in collaboration with KGMP

　　Regular registration status update to global and local stakeholders

　　Must-Have

　　Completed Bachelor's degree in any discipline

　　6 - 8 years of experience in a regulatory affairs role in medical devices industries

　　Good understanding and working knowledge of QARA Operations

　　Must have effective written and verbal communication skills in both English and Korean languages

　　Excellent stakeholder relationship management

　　Achievement oriented and ability to drive results with the highest quality standards

　　Computer skills (excellent knowledge of MS Office products)

　　Nice-to-Have

　　Medical devices and class IV product licensing experience is highly regarded

　　Korea Good Manufacturing Practice experience is a great plus

　　We Offer

　　In our 5th Tenet of our Mission, we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. Also, a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:

　　Flexible working environment.

　　Annual Incentive Plan % depending on company results.

　　Pension scheme and group discount on healthcare insurances

　　Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract

　　Employee Assistance Program and Recognize! (our global recognition program)

　　About Medtronic

　　Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

　　We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

　　Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services, and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries.

　　Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.

　　It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.