[루닛] (Seoul) Regulatory Affairs Specialist

[루닛] (Seoul) Regulatory Affairs Specialist

[모집기간]

채용 시 마감

[담당업무]

-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)

[우대조건]

-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

[채용공고]