Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective: 
This role supports the RA/QA 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.
  • Obtain documentation and information needed to submit to MFDS 
  • Assess suitability of documents for submission
  • Prepare Submission dossiers to MFDS
  • 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.

Education and Experience:
Bachelor’s Degree required, preferably in a Life Science or Bio-Engineering discipline.  
Training in technical aspects of regulatory affairs prefered.  3-5 years of direct experience in Regulatory Affairs in a medical device company required. 
Strong interpersonal, oral and written communication skills required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.