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¿Ü±¹°è RA (¾à»çÀÚ°ÝÁõ Çʼö) About the Role Are you an experienced Regulatory Affairs professional with a passion for ensuring compliance and supporting sustainable growth in the healthcare industry
Seeking a Regulatory Affairs Specialist to support regulatory submissions, product lifecycle management, and compliance activities within the Korean market.
This role plays a critical part in interpreting global regulatory guidelines and translating them into actionable local requirements, ensuring continuous product availability and adherence to national regulations.
Reporting to the RA Manager and partnering closely with cross-functional stakeholders such as QA, Sales, and
Marketing, you will contribute to regulatory documentation, support license maintenance activities, and facilitate communication with health authorities to enable timely approvals and updates.
Prior experience in healthcare, pharmaceuticals, or MedTech regulatory processes is highly valued.
Key Responsibilities [Regulatory Affairs ] Product registration of medicinal products and medical devices and life cycle management of product licenses Manage regulatory projects related to South Korea including regulatory maintenance Monitor policy updates and report key changes under guidance Support the maintenance of local RA SOPs to meet BRACCO SOPs and local regulations.
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