Director RA/QA

תיאור משרה

As our Director of RA/QA , 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
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.