Senior Manager, Regulatory Affairs
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 Senior Manager, Regulatory Affairs leads the development and execution of ex-US regulatory strategy for the company's NGS-based in vitro diagnostic (IVD) products, with a starting focus on the EU In Vitro Diagnostic Regulation (IVDR) and Health Canada, expanding over time to additional priority markets (e.g., UK/UKCA, Australia/TGA, China/NMPA, and other geographies as the international footprint grows). This role also owns the regulatory relationship with biopharma partners for companion diagnostic (CDx) and complementary diagnostic co-development programs, and maintains working knowledge of the US regulatory framework (FDA) to ensure a cohesive, globally a
