דרושים Director of RA/QA/Clinical Affairs בתל אביב

A 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