Medtronic
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 function supports the preparation, coordination, submission, tracking, and maintenance of regulatory documentation required to support product registrations and compliance activities across global markets. This team partners with cross-functional stakeholders to help ensure regulatory submissions are accurate, complete, and aligned with applicable requirements, while driving process efficiency and maintaining regulatory records and systems.
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.
Primary Responsibilities:
Coordinate the preparation, compilation, review, and submission of regulatory documentation required for registrations, renewals, amendments, annual reports, and other regulatory activities.
Manage the tracking, indexing, archiving, and maintenance of paper and electronic regulatory records and submissions.
Review submission documentation for completeness, accuracy, and compliance with applicable regulatory requirements and internal standards.
Collaborate with cross-functional stakeholders to collect, organize, and maintain documentation supporting regulatory filings.
Monitor regulatory activities, submission timelines, and system records to support compliance and reporting requirements.
Support regulatory labeling activities by providing recommendations aligned with applicable regulatory requirements.
Maintain regulatory databases, systems, and tools to ensure accurate documentation and traceability of regulatory information.
Monitor regulatory changes and communicate relevant updates that may impact submission strategies, processes, or compliance activities.
Required Qualifications:
Bachelor's Degree in Medical Sciences, Biological Sciences, Engineering, or a related technical discipline and a minimum of 3 years of regulatory, regulatory operations, quality, clinical, or related experience within a medical device, pharmaceutical, contract research organization (CRO), or similar regulated environment.
Business-level English proficiency in reading, writing, and speaking.
Korean language proficiency equivalent to TOPIK II Level 3 or Level 4, with the ability to read, write, and communicate professionally in Korean.
Knowledge of Korean regulatory requirements and regulatory submission processes.
Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
Preferred Qualifications:
Experience supporting regulatory submissions, registrations, renewals, or compliance activities for medical devices.
Experience working with global stakeholders across multiple regions and functions.
Experience using regulatory information management systems, document management systems, SAP, SharePoint, or similar business applications.
Knowledge of medical device regulatory frameworks within Asia-Pacific (APAC), the United States (US), or the European Union (EU).
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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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).