Remedy Robotics

Full-stack Engineer

• Build and improve core robot control software in C++
• Own system-level orchestration code in Python that ties our subsystems together
• Improve our simulation and test infrastructure
• Move across the stack as needed — whatever is currently the bottleneck
• Collaborate closely with ML, hardware, and clinical teams to ship end-to-end features
• Help define and harden the software architecture as we move toward IDE submission and clinical trial

Software Engineer – Generalist

Compliance

• Own the regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorization
• Serve as the primary FDA point of contact — pre-submission meetings, IDE submission, deficiency responses, panel preparation
• Define the regulatory strategy for our autonomous and AI/ML-enabled features, including a Predetermined Change Control Plan (PCCP) where appropriate
• Set OUS regulatory strategy (CE Mark / MDR, plus initial thinking on other markets) and sequence it against US timelines
• Author the IDE submission and lead the cross-functional authoring effort with engineering, clinical, and quality
• Own the regulatory portions of the design history file and ensure submission readiness across the company
• Write and own pre-submission Q-Sub packages
• Lead FDA inspection preparation and response
• Partner with the Head of Clinical Operations on the clinical sections of submissions — ClinOps owns trial execution and protocol authoring; you own how it lands at FDA
• Partner with Faiyaz (VP Program Management) on submission timelines and milestones
• Partner with the Quality Lead on QMS, IEC 62304, and the design control narrative
• Represent regulatory in executive and board updates

Software Engineer – Generalist

Head of Regulatory Affairs