Director RA/QA

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.
דרישות התפקיד
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