(Seoul) Regulatory Affairs Specialist at Lunit

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

17 Aug, 26

Salary

0.0

Posted On

19 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, SaMD, FDA Submission, CE MDR, MFDS, ISO 13485, IEC 62304, IEC 82304, ISO 14971, Technical Documentation, Regulatory Compliance, Analytical Skills, Problem Solving, Strategic Thinking, English Proficiency, Digital Health

Industry

Software Development

Description

*This position is open for candidates who reside in Korea and have a Korean proficiency appropriate for working in a Korean business. "Conquering cancer through AI" Lunit, a portmanteau of ‘Learning unit,’ is a medical AI software company devoted to providing AI-powered total cancer care. Our AI solutions help discover cancer and predict cancer treatment outcomes, achieving timely and individually-tailored cancer treatment. 🗨️ About the team At Lunit, the RA team is at the forefront of bringing AI innovation to the global market. We don't just follow regulations. We navigate the complex landscape of global registrations and audits to set new standards for SaMD. Our team thrives on collaboration, transparency, and a shared mission to ensure patient safety through cutting-edge technology. 🗨️ About the position Are you ready to start your career in the most exciting field of healthcare? We’re hiring a new RA Specialist who is eager to learn and grow within Lunit’s pioneering RA team. Join us on our journey as we redefine medical diagnostics through AI-based software and lead the global market as a true first mover. 👉 See a day in the life of the RA team 🚩 Roles & Responsibilities Support global regulatory submissions and product registrations (e.g., FDA, CE MDR, MFDS, Health Canada) for SaMD Maintain and update existing licenses and technical documentation to ensure continuous compliance Monitor and analyze global regulatory trends and pre-/post-market requirements for target markets Keep track of changes in international standards relevant to SaMD (e.g., ISO 13485, IEC 62304, IEC 82304, ISO 14971) Support internal and external audits/inspections by organizing and managing required regulatory document packages Conduct research on country-specific regulatory pathways to support the development of global market entry strategies Assist in communicating with external partners or regulatory bodies regarding submission inquiries 🎯 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 & 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.

Responsibilities

Support global regulatory submissions and product registrations for Software as a Medical Device (SaMD) across various international markets. Maintain technical documentation and monitor global regulatory trends to ensure continuous compliance and support audits.