About this role
Senior Research Development Manager at Seegene USA. Location: Irvine, California, United States. Role: leading projects, managing team, overseeing validation Requirements: Advanced degree in molecular/microbiology/biochemistry or related field with 3–7+ years molecular diagnostics experience, 3+ years people management, experience with FDA 510(k)/De Novo/EUA submissions, Design Controls and ISO 13485 knowledge. Category: Research and Development (R&D) Seniority: Senior Level Tools: PCR, Design Control, FDA 21 CFR Part 820, ISO 13485 Commitment: Full Time Workplace: Onsite Languages: English