Ra Manager

Abbott

Seongnam, South Korea
Not specified; not specified; not specified
Not specified
Mfds ivd medical device regulations knowledge
5-10 years regulatory affairs experience
Medical diagnostics industry expertise
Abbott is seeking a Regulatory Affairs Manager for its Rapid Diagnostics division in Seongnam, South Korea. The ideal candidate will have significant experience in regulatory affairs within the medical devices sector, particularly in in vitro diagnostics, alongside strong communication and project management skills

Job Summary

  • Lead and manage all regulatory activities for the Abbott portfolio in South Korea as part of the APAC RA regional team.
  • Drive regulatory strategies and submission plans while managing new product registrations, business licenses, and KC Certifications.
  • Develop and execute New Health Technology Assessment and reimbursement strategies while monitoring developing regulations.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Manager for its Rapid Diagnostics division in Seongnam, South Korea. The ideal candidate will have significant experience in regulatory affairs within the medical devices sector, particularly in in vitro diagnostics, alongside strong communication and project management skills.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • MFDS IVD medical device regulations knowledge
  • 5-10 years Regulatory Affairs experience
  • Medical diagnostics industry expertise
  • New Health Technology Assessment strategy
  • Chemicals Act registration management
  • Promotional material review responsibilities

Nice-to-have

  • Software as a Medical Device (SaMD) knowledge
  • Cross-functional multicultural environment navigation
  • Strategic opportunity identification skills
  • Team coaching and motivation capabilities
  • Strong network with healthcare policy makers

Key Requirements

  • Bachelor degree or higher in Biomedical/Medical Sciences or Engineering
  • Minimum 5-10 years experience in Regulatory Affairs for Medical Devices
  • Excellent written and oral communication skills in English and Korean
  • Strong knowledge of MFDS, US FDA, IVDR, and IMDRF regulations

Work Rights

Not specified

Tailored Resume

Cover Letter