Regulatory Affairs Specialist (Remote)

Who We Are

ABOUT ENOVIS™

What You'll Do

Job Summary:
This position effectively supports the complaint handling process by assessing complaints in a compliant and timely manner, for Medical Device MDR / Vigilance reportability of adverse event(s) to the FDA and other National Competent Authorities in the countries in which DJO distributes products to. This position is responsible for decision making, preparation, creation and submission of initial, supplemental and final reports to US, European and International NCAs. Works with local RA/QA representatives on determination and filing of foreign incident reports. Prepares responses to standard and extended requests from Competent Authorities and provides guidance and feedback to other team members pursuant to the corporate and site-specific procedures.