Regulatory Affairs Associate
At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.
As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.
It’s time for your next chapter. Discover your story with Adaptive.
Position Overview
The Regulatory Affairs Associate is responsible for assisting with assembling the regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and in international markets. This role also helps maintain FDA submission files and records, ex-US technical file documentation, and other documents and policies that support regulatory activities.
Key Responsibilities and Essential Functions
- Assists in writing and implementing process improvements for Regulatory Affairs functions
- Maintains and performs regulatory document filing and retrieval in conjunction with SO
