Sr. Software Regulatory Affairs Specialist
Core
Guide product teams through the regulatory pathway for medical device software from development to FDA submission, ensuring submissions are complete and defensible.
Role type
Senior Regulatory Affairs Specialist (Medical Device Software)
Builds
Regulatory submission packages for Class II and Class III medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
FDA submission preparation, Class II/III medical device regulations, software lifecycle documentation review, risk management assessment, cybersecurity evidence integration, cross-functional coordination
Preferred skills
Regulatory Affairs Certification (RAC), embedded software experience
Technologies
FDA submission systems, risk management tools
Responsibilities
Develop U.S. and international regulatory submission packages for new medical devices and changes to previously approved products; Define regulatory pathways for software development and product updates, identifying documentation and evidence gaps early in the development process; Assess software, firmware, and hardware changes to determine applicable filing requirements and supporting documentation; Review software lifecycle records, verification and validation results, risk management documentation, and cybersecurity evidence to support regulatory submissions; Integrate technical testing, product risk, and cybersecurity documentation into complete and defensible submission packages; Coordinate responses to regulatory agency questions by gathering technical input and preparing clear, focused responses; Maintain the regulatory compliance of approved products as functionality, technical documentation, and regulatory expectations evolve.