GANGNAMGU (1 Year Fix Term Contract) RA Specialist

Job description

(1 year fix term contract) RA Specialist Company: B. BRAUN KOREA CO. LTD. Job Posting Location: Gangnam-gu, Seoul Teugbyeolsi, Korea Functional Area: Regulatory Affairs Working Model: Onsite Requisition ID: 13009 Are you a RA Specialist passionate about RA planning and strategy for manageable regulatory risks? If so, this opportunity could be for you! Join us at B. Braun Korea, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As a RA Specialist at B. Braun you will play a vital role in… Manage regulatory affairs projects under his/her responsibilities agreed with RA Manager and Head of division Provide short/mid-term RA project plans to align with company strategy Ensure to complete regulatory affairs projects in timely manner according to milestone as agreed with RA manager and Head of division. Ensure product life cycle management and post approval change controls are done as required for the projects under his/her responsibilities. Provide regular assessment of post approval change control plan to mitigate the risk and prioritize the RA projects. Ensure planned regulatory risk management is done in timely manner Establish and maintain collaborative relationship with CoE GRA and internal stakeholders, as well as external stakeholders. Manage budget for responsible regulatory projects. Provide regular monitoring and business impact analysis of regulatory environment changes and share them with wider group as required to ensure alignment.