Regulatory Affairs Specialist

소개

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.

주요업무

• 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

자격요건

• 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, TD)

우대사항

• 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

혜택 및 복지

[루닛에서 일하는 것이 즐거운 이유!] Be the Next Lunitian ! Lunit+ Martian의 줄임말로 '암'이라는 행성을 정복하기 위해 노력하는 루닛 멤버들을 지칭해요 • 강남역 3번 출구 도보 1분 거리에 위치한 신규 오피스(언덕 없는 평지!) • 먹는 것에 진심인 우리, 강남 맛집 정복을 위한 12,000원의 식비 지원(점심,저녁) 및 무제한 간식 제공 • 입사 시 최신 사양의 컴퓨터 장비(Mac, 4K 모니터 등)선택, 3년마다 최신형 장비 지원 • 최고의 복지는 동료! 배울 점이 많은 훌륭한 동료들이 있어요 Learn and Grow with Lunit ! 배움으로써 성장하는 루닛이기에 구성원의 성장을 적극 지원해요 • 학회 참석 및 각종 직무 교육, 도서 구매 지원 • 의료? AI? 함께 공부해봐요, 정규 사내 인공지능/의료 세미나 개최 • 영어가 생활인 루닛, 업무 시간을 활용해 영어 회화 수업을 들어요 • 자유롭게 쓸 수 있는 복지 포인트 연간 120만원 지원 ＞ 루니션들은 어떤 환경에서 근무하고 있을까요? 오피스 자랑대회 3등 출신, 루닛의 강남뷰 맛집 오피스 구경하러 오세요! https://www.wanted.co.kr/events/office_Lunit