Senior Manager, Regulatory Affairs

Role: Senior Manager, Regulatory Affairs, leading ex-US regulatory strategy for Adaptive's NGS-based IVD products, focusing on EU IVDR and Health Canada, with expansion plans for additional markets. Responsibilities: develop and execute international regulatory roadmaps; serve as primary regulator with authorities and Notified Bodies; oversee technical files and post-market surveillance; lead regulatory strategy for biopharma co-developments and companion diagnostics; align US and global regulatory approaches; mentor team and collaborate with R&D, Quality, and clinical functions. Requirements: Bachelor's in life sciences or related; 12+ years in regulatory affairs within IVD, diagnostics, or medical devices; experience with EU IVDR and Health Canada submissions; 2+ years supervisory experience; knowledge of US FDA frameworks (510(k), De Novo, PMA); strong communication skills. Preferred: experience supporting biopharma CDx programs, clinical trial regulatory knowledge, and familiarity with additional international markets and data privacy considerations. Work setup: Office-based with domestic/international travel (~10%). High-value biopharma specifics include NGS assays, IVD regulatory frameworks, companion diagnostics, and global clinical/regulatory pathway development.