Regulatory and Quality Associate (Florida - React Diagnostics)

A Regulatory and Quality Associate is an entry level position with a focus on documentation of FDA records/reports, 510k submission materials, training materials, quality assurance activities, and continuous improvement processes. The goal is to deliver superior medical device hardware and software products to our internal and external customers.

Participate in any 510k initiatives including research and documentation

Participate in internal and vendor audits

Create and maintain controlled documents

Identify methods to improve our testing efficiency and time to find issues

Become knowledgeable about the ReactDx Quality System Manual

Conduct activities in accordance with FDA Design Controls

Comply with FDA guidelines, standards, and business defined documentation processes to provide quality deliverables

Perform all other duties as assigned