Regulatory Affairs Associate

About this role

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 SOPs Compiles, coordinates, and formats materials required in submissions, license applications, technical file documentation etc. Maintains files related to FDA/global regulatory registrations, including communications with FDA/Global regulatory agencies Coordinates and formats submissions per FDA and/or other global health authority requirements Assists in the creation and implementation of regulatory affairs department policies and procedures to ensure that regulatory compliance is maintained or enhanced Support operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product All other duties as assigned Position Requirements (Education, Experience, Other) Required Bachelor’s Degree 2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience Preferred Demonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output.