Regulatory Affairs Operations Specialist – Korean Bilingual

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

The Regulatory Operations Specialist (Korean Bilingual) supports regulatory submission and compliance activities by coordinating documentation, managing regulatory records, and collaborating with stakeholders across multiple functions. This role requires Korean language proficiency, knowledge of regulatory requirements in Korea, and the ability to manage multiple submissions and regulatory processes while maintaining accuracy and compliance.

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  Experience supporting regulatory submissions, registrations, renewals, or compliance activities for medical devices.

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  Experience working with global stakeholders across multiple regions and functions.

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  Experience using regulatory information management systems, document management systems, SAP, SharePoint, or similar business applications.

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  Knowledge of medical device regulatory frameworks within Asia-Pacific (APAC), the United States (US), or the European Union (EU).

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  Experience applying process improvement methodologies such as Define, Measure, Analyze, Improve, and Control (DMAIC) or similar continuous improvement approaches.

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. 

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