CDx Regulatory Lead - FDA Submissions & IVD Strategy

A leading biotechnology company in Boston seeks a Regulatory Affairs Specialist/Manager to lead regulatory strategies for diagnostic products. This role involves coordinating FDA submissions and collaborating with internal teams to ensure compliance with global regulatory standards. The ideal candidate will have 5-8 years of Regulatory Affairs experience, particularly in Diagnostics and Medical Devices. A hybrid work model allows for flexibility, and candidates must possess strong English fluency. Competitive compensation package offered, with a range of $71K-$143K. #J-18808-Ljbffr