CoPilotMD is pioneering the future of AI-powered healthcare software.
As our Director of RA/QA/Clinical Affairs, you’ll steer the development and execution of our regulatory, quality, and clinical operations strategies. This leadership role is ideal for someone eager to drive impact in a high-growth startup—especially across U.S. clinical trials and global compliance landscapes.
This is a part-time role during the first 12 months, with potential to grow into a full-time leadership position as the company scales.
What You'll Do Clinical Affairs:
Architect and execute U.S.-based clinical trials, from protocol development to site engagement and GCP-compliant execution
Identify and cultivate relationships with U.S.-based physician investigators, KOLs, and clinical research sites
Manage CROs and vendors for monitoring, recruitment, and data integrity
Partner with clinical teams and investigators on data analysis and study outputs
Lead publication efforts, from abstract through peer-reviewed journal submissions, in close collaboration with clinical sites
Regulatory & Quality Leadership:
Build and evolve an ISO 13485-compliant Quality Management System designed for digital health innovation
Oversee and mature our ISO 27001 Information Security Management System and ensure regulatory-grade cybersecurity practices
Own U.S. and EU regulatory submissions (FDA, CE, IVDR) for software-based medical devices, with a focus on AI/ML considerations
Ensure privacy and safety requirements (GDPR, HIPAA) are embedded throughout product development
Lead audits and inspections with regulatory bodies and notified entities
