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.

For the Abbott Rapid Diagnostics Infectious Disease - Emerging Markets Business Unit we are looking for an experienced, talented and dynamic regulatory professional to lead and manage all related RA activities for the Abbott portfolio for South Korea as part of the APAC RA regional team.

Location : 경기도 분당(정자역 근처)

Responsibilities:

• Drive, develop and support regulatory strategies and submissio n plans for South Korea in collaboration with project team, man ufacturing sites, supply chain, marketing, country manager and distributors.
• Work closely with the Legal Manufacturer RA team to ensure th e required regulatory submission documents and adequate level of information is provided in accordance MFDS requirements.
• Manage the preparation and submission of new product registra tions, 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 labor atory.
• 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 Assess ment and reimbursement strategy, support for local clinical stu dy.
• Monitor developing regulations and gather regulatory intelligen ce that may be relevant to the business. Conduct impact assess ment 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 t eam member,
• Promote awareness of regulatory requirements throughout the organization.
• Build strong network relationship with the local healthcare polic y 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 mana gement 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.