Regulatory Affairs Specialist

Requirements

🎯 Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field
• 0 to 3 years of experience in Regulatory Affairs within the medical device industry
• Fluent in English (both written and spoken) for managing global regulatory communications and technical documentation
• Basic understanding of medical device regulations (e.g., ISO 13485, MFDS, FDA, or EU MDR)
• Strong interest in SaMD (Software as a Medical Device) and Digital Health
• Proactive learner with strong analytical and problem-solving skills to navigate evolving regulations
• Strategic thinking and a logical approach
• Well-structured documentation skills (Submission dossiers, Technical Documentation)

🏅 Preferred Experiences

• Experience in SaMD (Software as a Medical Device) and Digital Health
• Involvement in US FDA (510(k)) or EU MDR (CE) submission processes
• Understanding of Change Management (labeling, software updates) and its regulatory impact

📝 How to Apply

• Resume, Cover letter (Korean and English)

🏃‍♀️ Hiring Process

• Document Screening → Competency-based Interview (Online) → Peer Interview (On-site) → Culture-fit Interview (On-site) → Onboarding
  • After the final interview, we may proceed with reference checks if needed.

🤝 Work Conditions and Environment

• Work type: Full-time (3-month probation)
• Work location : Lunit HQ(5F, 374, Gangnam-daero, Gangnam-gu, Seoul)
• Salary: After negotiation

🎸 ETC

• If you misrepresent your experience or education or provide false or fraudulent information in or with your application, it may be grounds for cancellation of the employment.
• Lunit is committed in providing the preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related laws and regulations.

Benefits

🌻 Benefits & Perk

• The office is at a very convenient location, just a minute away from Gangnam Station Exit 3.
• Meal Allowance is provided (up to 12,000 KRW per meal) when working at the office.
• Latest computer models, such as Macs and 4K monitors are provided and can be renewed every three years.
• Seminar registration fees and book purchases are covered.
• Regular in-house AI and medical seminars are held.
• In-house English lessons (aka Luniversal) are provided for English development.
• Access to high-quality AI learning resources & deep learning DevOps system.
• Up to 1.2 million KRW worth of benefits points can be claimed annually.
• Holiday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and Chuseok.
• Congratulatory and Condolence allowances, along with paid time off are provided.
• Annual medical checkups and employee accident insurance are provided.