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Job Details

  • Title:
    RA Specialist, ARK
  • City:
    Seoul
  • Country:
    South Korea
  • Company:
    Arthrex Korea

Description

Main Objective:

This role supports the RA Manager to ensure Arthrex Korea meets RA requirements and processes quality control in accordance with regulatory and corporate standards. This role contributes to Arthrex Korea’s business results by providing accurate and proper RA information and services to business team.

 

Essential Duties and Responsibilities:

Registration of new/changed products

  • Executes assigned tasks to obtain regulatory approvals for new or changed products as per project plan.
    1. Obtain documentation and information needed to submit to MFDS
    2. Assess suitability of documents for submission
    3. Prepare Submission dossiers to MFDS
    4. Submits for MFDS Re-evaluation and Product License Renewal (note: from 2021) and update the licenses as required.
  • Updates the registration tracking database and submits other reports such as RA Projects Weekly Report and Registration Status File accordingly for other stakeholders such as Marketing, SCM, etc.
  • Maintain Technical File dossiers in the archive for traceability and data protection.

Regulatory Compliance

  • Assists RA/QA Manager on ensuring all regulatory compliance in place.
  • Performs gap assessment to identify regulatory risk and mitigate in a timely manner.
  • Provides consultation to other functions in relation to regulatory approval status.

 

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Requirements

Education and Experience:

  • Bachelor’s Degree required, preferably in a Life Science or Bio-Engineering discipline. 
  • Training in technical aspects of regulatory affairs preffered.  5+ years direct experience in Regulatory Affairs in a medical device company required.
  • Strong interpersonal, oral and written communication skills required.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • High degree of understanding of regulatory requirements, scientific methods, and engineering fundamentals.
  • Ability to work in fast paced environment and handle multiple tasks and requests.
  • Has gained comprehension of orthopedic technical/engineering/medical terminology, or can reference literature for understanding.

 

To apply, please send your CV to korea_recruiting@arthrex.kr