Ra Specialist

Abbott

Seongnam, South Korea
Not specified; base pyy n/a; range may vary by loc...
Not specified
Mfds medical device regulations knowledge
Ivd regulatory submission dossier preparation
Korean and english communication skills
Abbott is seeking a Regulatory Affairs Specialist for its Rapid Diagnostics division in Seongnam, South Korea. The role focuses on managing regulatory submissions, ensuring compliance with local regulations, and supporting product registrations, particularly in the field of In Vitro Diagnostics

Job Summary

  • The role involves leading all Regulatory Affairs activities for the Abbott portfolio in South Korea as part of the APAC regional team.
  • Responsibilities include managing new product registrations, maintaining submission dossiers, and ensuring ongoing compliance with Korean regulations.
  • Candidates must possess strong working knowledge of MFDS regulations, EU IVDR, US FDA standards, and ISO 13485.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Specialist for its Rapid Diagnostics division in Seongnam, South Korea. The role focuses on managing regulatory submissions, ensuring compliance with local regulations, and supporting product registrations, particularly in the field of In Vitro Diagnostics.

Salary

Not specified; Base pay N/A; Range may vary by location

Skills & Requirements

Must-have

  • MFDS medical device regulations knowledge
  • IVD regulatory submission dossier preparation
  • Korean and English communication skills
  • Product lifecycle regulatory compliance management
  • Promotional material review and approval

Nice-to-have

  • RAC Level 2 certification preferred
  • Strong cross-functional collaboration skills
  • Proactive risk identification and mitigation
  • Relationship building with local authorities
  • Solution-oriented mindset for challenges

Key Requirements

  • Bachelor's degree in Biomedical Engineering or Life Sciences
  • 2-3 years of Regulatory Affairs experience in Medical Devices
  • Experience specifically with In Vitro Diagnostics (IVDs)
  • Fluency in written and verbal English and Korean

Work Rights

Not specified

Tailored Resume

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