RA Project Specialist

1 month ago


Singapore Abbott Laboratories Full time

RESPONSIBILITIES

  • Responsible for Singapore and the assigned countries within SEA.
  • Work with Global Regulatory Affairs to plan, schedule, and manage the process of preparing, coordinating and submitting regulatory applications to local Regulatory Authority.
  • Support local EU MDR regulatory submission and approval.
  • Ensure regulatory approvals are obtained for all marketed devices and general management of registration functions are performed in accordance with regulatory guidelines and company internal procedure.
  • Proactively monitor, review and manage internal tracking for licenses that are expiring.
  • Update and maintain regulatory submissions and approvals in the designated systems / database in accordance to the internal requirements.
  • Work with local Supply Chain and Commercial teams to mitigate supply risks.

QUALIFICATIONS

  • At least a Diploma/Degree
  • Fresh graduate with minimum or no working experience
  • Training will be provided
  • Proficient in the use of MS Word, Excel and PowerPoint
  • Good spoken and written of English language
  • Able to work independently and possess great sense of responsibility and accountability


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