Sr. Software Regulatory Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Software Regulatory Affairs Specialist based in the United States.

This remote opportunity is ideal for a regulatory affairs professional with strong expertise in medical device software and FDA submissions. You will guide product teams through the regulatory pathway from software development to successful submission, helping identify evidence gaps before they delay product releases. The role covers Class II and Class III medical devices, including standalone software and products integrating software with hardware and mechanical components. You will work closely with engineering, quality, and product teams to connect technical documentation, risk management, testing, and cybersecurity requirements. Your work will help ensure submissions are complete, defensible, and aligned with applicable regulatory expectations. You will also support ongoing compliance as products evolve and regulations change.