Location: Seoul Capital Area
Contract Type: Permanent
Salary: ₩65,000,000 – ₩80,000,000 per annum
An international medical device company is searching for a Sr. Regulatory Affairs Specialist. The chosen applicant will be responsible for developing strategies and ensuring regulatory approvals for assigned product line.
Responsibilities:
- Develop and execute strategies for regulatory approvals, including new product registrations, license renewal, and KGMP certifications
- Ensure timely submissions and approvals through high-quality regulatory applications aligned with committed timelines
- Collaborate with global and regional RA peers to align strategies and provide regulatory support
- Serve as a regulatory consultant to the marketing team to support business objectives
- Ensure compliance across the product lifecycle, including labelling, promotional review, and product change management
- Support internal and external audits related to company-owned products
- Monitor and assess emerging regulatory trends and share updates with internal stakeholders
- Represent the company in industry associations and contribute to regulatory policy development
- Build and maintain constructive relationships with local health authorities through quality submissions and timely responses
Requirements:
- Bachelor’s degree or above in biomedical engineering, life sciences, or a related field
- 7-9 years of experience in Regulatory Affairs within the medical device industry
- Strong knowledge and understanding of medical device regulations covering pre-market and post-market management
- Familiarity with Digital Medical Product regulations or post-market surveillance requirements is desirable
- Skilled in MS Office is preferred
- Proficient in written and verbal English
About the Company:
An international researcher and manufacturer of medical devices, the company aims to better the lives of clients around the globe. Through careful research, they develop new processes while improving the capabilities of others, lowering risks, and raising the bar for global health.