Regulatory Affairs Specialist- PDx

Job Description SummaryWe are seeking a passionate and driven individual to join GE HealthCare’s Regulatory Affairs (RA) team. The RA Specialist / Sr. RA Specialist will be responsible for obtaining and maintaining product registrations and business licenses in accordance with local regulations, company SOPs, and the strategic direction set by the GRL (Global Regulatory Lead). This role will serve as a vital regulatory partner to local cross-functional teams and global stakeholders to support product launches and ensure compliance throughout the product lifecycle.Job Description[HR Talk]GE헬스케어 조영제 사업부에서 RA 업무를 담당하실분을 채용합니다. 제약회사나 헬스케어 분야에 관심있으시고 관련 업무를 최소 1년 하신 후보자를 우대하며 한국어 및 영어 커뮤니케이션이 매우 적극적으로 가능하신 후보자를 선호합니다.Product Registration & MaintenanceDevelop regulatory strategies aligned with the product launch plan and GRL direction.Prepare and submit MFDS applications in accordance with Korean regulations and GE HealthCare SOPs.Collaborate with GRL and internal cross-functional teams to implement bridging strategies for marketing authorization.Maintain product licenses by updating CMC, CCDS, and safety information as needed.Review promotional and external communication materials for regulatory compliance.Manage business licenses to support commercial operations.Cross-functional Regulatory SupportProvide timely and accurate regulatory insights to internal teams (Medical, Commercial, Quality, etc.).Participate in cross-functional projects and provide regulatory perspectives in decision-making processes.External Collaboration & Regulatory IntelligenceBuild and maintain effective working relationships with MFDS, MoHW, and relevant industry associations.Monitor local regulatory changes and contribute to shaping policies aligned with GE HealthCare’s business strategy.Represent GE HealthCare in regulatory forums when required.QualificationsMinimum 1 year of experience in Regulatory Affairs within the pharmaceutical or healthcare industry or Health authority (MFDS etc.).Degree in Pharmacy or Life Sciences. Pharmacist license is preferred.Fluent in Korean and English (both written and verbal communication).Solid understanding of Korean pharmaceutical regulations and regulatory procedures.Knowledge of drug development and product lifecycle management.Inclusion and DiversityGE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.Additional InformationRelocation Assistance Provided: No