About Abbott : Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 애보트래피드진단(Abbott Rapid Diagnostics, Inc.)은 한국애보트의 신속진단 사업부로서 의료기기 및 체외 진단시약을 생산하는 Abbott Rapid Diagnostic Division의 한국법인으로 현장진단 검사의 세계적인 리더 기업입니다. Primary Job Function : Complete day to day supply chain tasks including order processing, data entry, issue investigation and resolution, handling general customer enquiries (phone and email), stock management, credit and invoice management.

Location : 경기도 분당(정자역 근처) Responsibilities: • Drive, develop and support regulatory strategies and submission plans for South Korea in collaboration with project team, manufacturing sites, supply chain, marketing, country manager and distributors. • Work closely with the Legal Manufacturer RA team to ensure the required regulatory submission documents and adequate level of information is provided in accordance MFDS requirements. • Manage the preparation and submission of new product registrations, business licenses, permits and amendments including per iodic renewals and revisions in accordance with legal/regulatory /compliance requirements, and local business needs. • Manage the preparation and submission of KC Certifications ap plication and supporting the required testing at applicable laboratory. • Manage the preparation and maintenance of chemical materials in accordance with registration and evaluation requirements of Chemicals act and Chemicals Control Act. • Effectively develop and execute New Health Technology Assessment and reimbursement strategy, support for local clinical study. • Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders. • Develop, manage and report metrics to track and trend defined Key Performance Indicators for RA South Korea. • Responsible for review of promotional material for South Korea. • Develop, motivate and coach and provide guidance to local RA team member. • Promote awareness of regulatory requirements throughout the organization. • Build strong network relationship with the local healthcare policy makers, regulatory agencies and local industry associations. • Promote teamwork and establish good working relationship at Affiliate level and across the organization. • Perform other activities or special projects as assigned by management or direct supervisor.

Qualifications: • Bachelor degree or higher degree in Biomedical/Medical Sciences or Engineering. • A minimum of 5-10 years’ experience in Regulatory Affairs in Medical Devices, preferably in IVDs. • Demonstrable working knowledge of the medical diagnostics industry, including Software as a Medical Device (SaMD) • Demonstrated capacity in project management. • Able to navigate in a cross functional and multicultural environment. • Strong knowledge of MFDS IVD medical device regulations and regulatory framework including SaMD, US FDA, IVDR (EU 2017/746), IMDRF and international digital health regulations. and requirements, legislation, industry standards and guidance. • Excellent written and oral communication skills in English and Korean. • Strong interpersonal and negotiation skills. • Capacity to identify strategic opportunities and recognize threats. • Ability to anticipate risks and develop mitigation plan. • Solution oriented, organized with good attention to details. • Highest levels of integrity and diplomacy. • Capacity to maintain the highest levels of confidentiality internally and externally.

• APAC Head에게 리포트 하는 포지션 입니다. 이력서는 영문으로 작성 바랍니다. • •

1차 실무자 인터뷰 2차 임원 인터뷰 3차 인사부 인터뷰 & 인적성 검사

4대 보험 / 장기근속수당 / 야근수당 / 퇴직금 / 우수사원포상 / 포상인센티브제 / 인센티브제 / 캐주얼데이 / 생일선물 / 명절선물 / 리프레시 보건휴가 / 남성출산휴가 / 육아휴직 / 산전 후 휴가 / 포상휴가 / 휴가비지원 / 근로자의 날 휴무 / 창립일 휴무 / 경조휴가제 / 반차 연차 / 노트북 / 카페테리아 / 회의실 / 생활식비 지원 / 사내 동호회 운영 / 리더십 강화교육 / 직무능력향상교육 / 신규 입사자 교육(OJT) / 출퇴근 회사차량 있음 / 주차비지원 / 주차장제공 / 차량유류비지급 / 자녀 학자금 / 본인 학자금 / 선택적복리후생 / 통신비 지원 / 단체 상해보험 / 의료비지원(본인) / 건강검진