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.

Job Summary:

• Ensure the preparation, compilation, and maintenance of regulatory submission dossiers for new and changed product registrations. 
• Support the development and implementation of regulatory strategies in alignment with local regulatory requirements and business objectives. 
• Ensure ongoing regulatory compliance with applicable South Korean regulations throughout the product lifecycle. 
• Monitor changes in local regulations and perform regulatory impact assessments to evaluate potential effects on the business. 
• Review and approve promotional materials for South Korea to ensure compliance.

Job Responsibilities:

• Manage new product registrations and product change registrations, including support for local clinical performance studies where required. 
• Prepare, compile, and maintain regulatory submission dossiers to support new and changed product registrations. 
• Collaborate closely with the Legal Manufacturer Regulatory Affairs team to ensure all submission documents meet Health Authority requirements and reflect an adequate level of regulatory information. 
• Provide regulatory strategy input and support throughout the product lifecycle. 
• Ensure ongoing regulatory compliance with applicable Korean regulations. 
• Proactively identify regulatory risks and develop mitigation plans to minimize business impact. 
• Monitor changes in local regulations, assess regulatory intelligence, and evaluate potential impacts on the business. 
• Conduct regulatory impact assessments related to product change control activities. 
• Review and approve promotional materials intended for use in South Korea to ensure compliance. 
• Manage KC Mark certification, including application submission and coordination of required testing. 
• Support reimbursement-related activities associated with new product registrations, as applicable. 
• Build and maintain strong working relationships with local regulatory authorities and industry associations. 
• Establish effective cross-functional collaboration with internal stakeholders across the organization. 
• Perform additional regulatory activities or special projects assigned by management.

Location : 분당(정자역 도보 5분거리)

Minimum Requirements:

• Bachelor’s degree or higher in Biomedical Engineering, Medical Sciences, Life Sciences, Immunology, Chemistry, or a related discipline.
• Minimum of 2-3 years of Regulatory Affairs experience in Medical Devices, preferably with a focus on In Vitro Diagnostics (IVDs).
• RAC (Regulatory Affairs Certification) at Level 2 preferred.
• Strong working knowledge of MFDS medical device and IVD regulations, requirements, legislation, industry standards, and guidance, including EU IVDR (EU 2017/746), US FDA regulations, ISO 13485, KGMP.
• Good written and verbal communication skills in both English and Korean.
• Good interpersonal, collaboration, and negotiation skills.
• Solution-oriented mindset with the ability to proactively resolve regulatory challenges.