Regulatory Affairs Specialist

Position Summary

The Regulatory Affairs Specialist is responsible for identifying and obtaining scientific, engineering, and regulatory information for review, preparation, and maintenance of technical documentation for submission to regulatory authorities in the countries/regions where the company wishes to market medical products. This position works with the regulatory authorities, or with the local subsidiaries or distributors taking action on behalf of the company, to ensure compliant market access. In addition, this person is responsible for review of promotional material and labeling for compliance with regulations, overseeing annual establishment registrations and device listings, and supporting on-going compliance projects. This position reports to the Head of Regulatory Affairs for ClearCorrect Operating, LLC.

Job Responsibilities

This position is responsible for, but not limited to, the following:

• Coordinate acceptance and managemen...