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 aligned regulatory strategy. This individual will be a key strategic partner to the VP, Regulatory & Quality as the company builds out its clinical program, and will help shape international clinical and regulatory pathways for future NGS-based clinical trials and CDx submissions. Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day. Key Responsibilities and Essential Functions International Regulatory Strategy • Own and evolve the company's ex-US regulatory strategy, prioritizing EU IVDR (technical documentation, Notified Body engagement, serve as PRRC, EU Declaration of Conformity) and Health Canada (Medical Device License applications, License amendments, Class III/IV IVD requirements) as the initial core markets. • Build the regulatory roadmap for future international expansion (e.g., UKCA, TGA, NMPA, other APAC/LATAM markets), including market-entry sequencing, gap assessments, and localization requirements. • Serve as primary point of contact and lead negotiator with international regulatory authorities and Notified Bodies; plan and lead regulatory agency/Notified Body meetings with support of the internal Regulatory leadership. • Monitor global regulatory intelligence (IVDR amendments, Health Canada guidance, IMDRF harmonization efforts, etc.) and translate changes into actionable strategy and internal process updates. • Own and maintain international technical files, design dossiers, and post-market surveillance/vigilance reporting obligations in coordination with Quality. Biopharma & Companion Diagnostics • Serve as the regulatory lead for biopharma co-development and companion diagnostic partnerships, aligning CDx regulatory strategy with partner drug development timelines (US and international). • Represent the company in regulatory discussions with biopharma partners and, where applicable, joint health authority interactions related to CDx submissions. • Provide regulatory input into companion/complementary diagnostic labeling, indications for use, and co-development agreements. • Support integ