Regulatory Affairs Associate
Adaptive Biotechnologies
Summary
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.
Job description
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
Requirements
- 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
Benefits
- Equity Grant
- Bonus Eligible
Company overview
Adaptive Biotechnologies is a pioneering commercial-stage biotechnology company that specializes in immune-driven medicine, focusing on harnessing the adaptive immune system to transform disease diagnosis and treatment. Founded in 2009 and headquartered in Seattle, Washington, the company has developed a proprietary immune profiling platform that reveals and translates insights from the adaptive immune system with unprecedented scale and precision. Adaptive's core technology decodes the genetic information of T-cell and B-cell receptors to identify signatures of immune response, enabling more precise monitoring and targeted therapeutic development. The company's flagship products include clonoSEQ®, the first and only FDA-cleared assay for minimal residual disease (MRD) testing in select blood cancers, which has become a standard in hematologic malignancy monitoring. Additionally, Adaptive offers immunoSEQ® for high-throughput immune repertoire profiling and T-Detect™ for infectious disease detection. With over 100,000 patients tested and more than $200 million in MRD revenue, Adaptive has established itself as a leader in immune medicine. The company collaborates with pharmaceutical partners, clinicians, and academic researchers to develop products that transform how diseases such as cancer, autoimmune conditions, and infectious diseases are diagnosed and treated, with the ultimate goal of creating personalized immune-driven diagnostics and therapeutics.