Base: not specified; bonus/equity: not specified; ...
Not specified (assumed to be on-site based on location details).
Manage new product registrations
Prepare regulatory submission dossiers
Review promotional materials for compliance
Abbott Rapid Diagnostics is seeking a Regulatory Affairs Specialist to manage regulatory activities for their portfolio in South Korea, particularly focused on compliance and registration of medical devices and diagnostics. The role requires strong knowledge of local and international regulations, along with at least 2-3 years of relevant experience
Job Summary
This role leads all Regulatory Affairs activities for the Abbott portfolio in South Korea as part of the APAC regional team.
The incumbent is responsible for preparing submission dossiers, ensuring ongoing compliance with Korean regulations, and managing KC Mark certification.
Candidates must possess strong working knowledge of MFDS regulations, EU IVDR, US FDA standards, and ISO 13485 to support the Infectious Disease business unit.
Matching Summary
Match Score: 85
Abbott Rapid Diagnostics is seeking a Regulatory Affairs Specialist to manage regulatory activities for their portfolio in South Korea, particularly focused on compliance and registration of medical devices and diagnostics. The role requires strong knowledge of local and international regulations, along with at least 2-3 years of relevant experience.
Salary
Base: Not specified; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Manage new product registrations
Prepare regulatory submission dossiers
Review promotional materials for compliance
Monitor local regulatory changes
Collaborate with legal manufacturer team
Nice-to-have
Strong cross-functional collaboration skills
Proactive risk identification mindset
Solution-oriented problem solving approach
Key Requirements
Bachelor's degree in Life Sciences or related field
2-3 years Regulatory Affairs experience in Medical Devices