Regulatory Affairs Specialist

Company Description

Dormotech Medical Ltd. is a digital health company revolutionizing the diagnosis and monitoring of sleep disorders through its innovative DormoVision X™ solution. Designed for patient-friendly self-setup at home, DormoVision X™ is a compact, multi-channel, reusable device suitable for both adults and children. It enables scalable remote diagnostics over multiple nights, making sleep studies more accessible, accurate, and efficient. By providing real-time monitoring and clinical-grade data, Dormotech is committed to improving patient outcomes and empowering healthcare providers to meet modern digital health standards.

Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist, based in Raanana. The Regulatory Affairs Specialist will be responsible for preparing, managing, and maintaining regulatory documentation and submissions. The role involves ensuring compliance with regulatory requirements, monitoring changes in regulations, and supporting the preparation for audits and inspections. The candidate will work closely with cross-functional teams to ensure adherence to national and international regulatory standards.

Key Responsibilities

• Lead and maintain compliance with ISO 13485 Quality Management System
• Support and manage regulatory submissions under EU MDR
• Support compliance with MDSAP requirements (US, Canada, etc.)
• Prepare, review, and maintain technical documentation (e.g., Technical File, DHF, risk management files)
• Interface with notified bodies, auditors, and regulatory authorities
• Support internal audits, external audits, and continuous improvement activities
• Work closely with R&D, clinical, and operations teams throughout the product lifecycle

Qualifications

• Experience with Regulatory Documentation and preparing comprehensive documentation to meet regulatory standards
• Strong knowledge of Regulatory Compliance and understanding of applicable laws and guidelines, specifically of ISO13485, EU MDR, MDSAP.
• Proven experience in Regulatory Affairs, including managing processes, audits, and inspections
• Skilled in preparing and managing Regulatory Submissions for national and international markets
• Attention to detail and ability to manage multiple tasks in a deadline-driven environment
• Bachelor's degree in Life Sciences, Pharmacy, Healthcare, or a related field

Nice to Have

• Experience with sleep, monitoring, or wearable medical devices
• Experience with FDA submissions (e.g., 510(k))
• Background in engineering, biomedical sciences, or a related field