[외국계 의료기기] Solta Medical Korea - RA Manager, Regulatory Affairs (Thermage FLX 등) - Solta Medical Korea, 솔타메디칼코리아(유)

Solta Medical Korea

[외국계 의료기기] Solta Medical Korea - RA Manager, Regulatory Affairs (Thermage FLX 등)

서울 기획,사업개발,전략기획 / 의료기기 / 바이오,의약,제약 2026.04.24 ~ 2026.05.24

Tasks

Develop and execute efficient regulatory strategies in Korea, ensure the alignment with business objectives, make sure the regulatory compliance of Solta Korea;
Work closely with regional team to proactively provide professional and strategic regulatory input to new R&D projects, lead cross functions to plan, prepare registration submissions in Korea, seek for earlier product approvals, including the necessary approvals from health authority and other authorities;
Lead and coordinate the interaction with MSDS, and local test labs;
Deeply engage in the development of clinical evidence generation and the strategy of clinical studies in Korea or global;
Work as the primary contact for Korea regulatory intelligence, interpret and monitor Korea regulation, provide regulatory input and assessment for regulatory and product changes;
Review and approve advertising, promotional materials and labeling to ensure regulatory compliance;
Provide strong support to commercial, supply chain, QA team etc.;
Support and coordinate the registration submission in other APAC countries.

Requirements

Bachelor degree or above in life science, engineering or mechanical discipline;
Minimum 8-10 years regulatory affairs experience in MNCs, regulatory knowledge of Japan and other APAC countries is a plus;
In-depth understanding of Korea regulatory framework and registration requirement, solid hands-on submission experience and strong technical skills associated with active medical devices are a must, familiar with the requirement from key IEC and ISO medical device standards, experience with RF, laser or ultrasound device registration is a plus, aesthetic device is a plus;
Experience with medical device clinical review, clinical data analysis and clinical trials;
Team player with the ability to work independently in a fast-paced and dynamic environment, adapt to the change, good interpersonal skills and personal influence;
Fluency in written and spoken English.

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