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Global Regulatory Data Coordinator

2 weeks ago

Kulim, Kedah, Malaysia Teleflex Full time
Job Description

We are seeking a highly organized and detail-oriented individual to join our team as a Regulatory Data Management Specialist. In this role, you will be responsible for reviewing and understanding the differences between various IPNs to determine which IPN ties to which MR, license, amendment, 510(k), PMA, letters to file, and/or Regulatory Impact Assessment.

You will create SCT entries and/or blocks for all IPNs and for all global markets, including US/CA, where a SCT entry and/or block does not already exist. Additionally, you will review and approve Agile documentation required to process SCT updates.