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 Manager – IVD/CDx is responsible for developing and executing US FDA and EU regulatory submission activities to support the development and commercialization of in vitro diagnostic (IVD)/LDT and companion diagnostic (CDx) products. This role includes leading the preparation of FDA pre-submissions, IDE, 510(k), PMA, and EU Technical Documentation under IVDR. The manager will collaborate cross-functionally with R&D, Quality, Medical Affairs, and Business Development to ensure regulatory compliance and successful market access.
This is a temporary, full-time position anticipated to last 6-months in duration.

REGULATORY AFFAIRS RESPONSIBILITIES

• New Product Development: Lead and coordinate the preparation, submission, and maintenance of regulatory filings with the U.S. FDA (Pre-Sub, IDE, 510(k), PMA) and EU Competent Authorities/Notified Bodies (Technical Documentation, Performance Evaluation Reports, and IVDR submissions). Develop and implement regulatory strategies to support companion diagnostic (CDx) programs in alignment with drug development timelines and FDA/CDRH/CDER/Notified Bodies expectations.
• Premarket Regulatory Strategy: Contributes to regulatory plans and strategy; advises how various decisions may affect submissions and associated timelines. Considers relative value of several alternative solutions to potential issues before confirming a final decision as to the path forward
• Change Assessment: Performs timely regulatory assessments to support Adaptive’s change control process, such as need for 510K, notifications, etc. Develop and execute change notification strategies for registered products globally, including US FDA and EU IVDR compliance.
• Regulatory Intelligence: Maintains current knowledge of regulatory requirements in markets for which product/service is offered. Reviews, identifies, and disseminates changes, and collaborates with quality system process owners to interpret applicable regulations and to mitigate any gaps. Monitor and interpret global regulatory requirements for IVDs, CDx, LDTs, and related regulatory pathways in the U.S., EU, and ex-U.S. markets.
• Labelling Review: Reviews labelling for products and services for compliance with regulatory requirements
• Post-market Surveillance: Supports PMS activities by compiling and assessing regulatory information to prepare surveillance reports (e.g. new or revised standards, expanded claims, recalls, adverse events, and impact on products and services)
• Regulatory Processes: Understands processes, procedures and systems used to accomplish work and recognizes downstream impact on other functions or sub-functions. Expert with tools and processes that support work including managing regulatory files, plans, and requirement documents.
• All other duties as assigned