Sr. Software Regulatory Affairs Specialist

The Sr. Software Regulatory Affairs Specialist role provides a clear pathway for product teams to navigate from software development to regulatory submission, ensuring evidence gaps are identified before release. This position involves building U.S. and international submission packages for new products and changes to approved devices, while evaluating software, firmware, and hardware updates to determine filing requirements. The specialist connects software testing, risk management, and cybersecurity evidence into defensible submissions, resolving agency questions and maintaining product compliance as regulations evolve. Additionally, the role helps engineering and quality teams translate regulatory requirements into development decisions and release plans.