Regulatory Affairs Specialist SEA

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:

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

Essential Duties and Responsibilities:

• Regulatory Changes (RA Compliance and Document Control)
  • Performing analysis of change assessments to provide regulatory impact and associated information to the global change management team
  • Maintaining accurate and complete change information to demonstrate traceability of chan...