Regulatory Affairs Associate

Role: Regulatory Affairs Associate supporting the registration and compliance of in vitro diagnostic devices (IVDs) in the US and international markets. Responsibilities: assist in preparing regulatory submissions, maintain FDA and global regulatory files, coordinate submission formatting, and update on standards and regulatory changes impacting IVD products; contribute to policy implementation and project contract review for regulatory guidance. Requirements: Bachelor's Degree, 2+ years in regulatory affairs within diagnostics or pharma, knowledge of FDA guidelines, experience with IVDs, molecular diagnostics, PCR, sequencing, or CLIA labs preferred. HighValue: focus on IVD diagnostics, regulatory submissions for US and global markets, FDA and QSR compliance, molecular diagnostics, PCR-based assays, sequencing technologies, or CLIA labs. WorkSetup: not specified, likely office-based or hybrid; no travel explicitly mentioned.