Director, RA/QA/Clinical Affairs (Part-Time)

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

What You Bring?

• BSc or higher in science, engineering, or health-related discipline
• Certified Lead Auditor (ISO 13485 / ISO 27001)
• Deep understanding of FDA CFR 820, ISO 13485, ISO 14971, ISO 27001, IEC 62304, IVDR 2017/746, GDPR, HIPAA
• Proven success managing regulatory and clinical strategies in medical device or digital health contexts
• Hands-on experience with AI/ML compliance frameworks and cybersecurity in healthcare
• Outstanding written and verbal communication skills in English
• A proactive, resourceful mindset with the ability to lead in a fast-moving, lean environment

***Position Type: Part-Time (60%, ~3 days/week) for the first 12 months