Manage and execute new submissions and renewal activities for medical device licenses, as well as post‑approval regulatory maintenance for all Korea products
Serve as a core team member for the KR MDR project, supporting long‑term regulatory strategy and execution through early engagement and license lifecycle continuity
Perform license maintenance activities while ensuring compliance with internal regulations and Korean health authority requirements
Coordinate with internal cross‑functional stakeholders (Global Regulatory Affairs, Quality, Supply Chain, and Commercial teams) to support regulatory deliverables and timelines
Prepare, compile, submit, and maintain regulatory documentation in accordance with MFDS requirements
Monitor changes in Korean regulations and assess potential impacts on existing licenses and future submissions

Bachelor’s degree in a scientific, engineering, or related field; Pharmacist license is preferred
At least 5 years of experience in Regulatory Affairs for medical devices, preferably with MFDS regulations
Hands‑on experience with medical device license submissions and license maintenance activities
Strong knowledge of Korean medical device regulations and product lifecycle management is preferred
Strong project management skills with the ability to manage multiple regulatory activities independently
Excellent communication skills in Korean and English (written and verbal)

Regulatory Affairs Specialist

Key skills