Regulatory Affairs Specialist: AI in Pharma & Med Devices

Synefi is seeking a Regulatory Affairs professional to join our compliance team in Boston. You will help ensure our AI-enabled pharma and medical device solutions meet FDA, EU, and GxP requirements throughout product development. You will monitor regulatory changes, develop validation protocols and documentation, advise engineering teams on regulatory implications, support clients with regulatory strategy for AI deployment, and prepare submissions, audit responses, and compliance reports.