Job Description:

• 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.

Qualifications:

• 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.