Regulatory Specialist

Regulatory Specialist Company Description

Dormotech Medical Ltd. is a digital health innovator transforming the diagnosis and monitoring of sleep disorders. Our flagship solution, DormoVision X™, is a compact, multi-channel, reusable home-based platform designed for both adults and children. By enabling scalable, accurate, and multi-night remote diagnostics, Dormotech improves accessibility and efficiency in sleep medicine.

Our technology provides healthcare professionals with real-time monitoring, clinical-grade physiological data, and an advanced patient-centered digital health experience aligned with modern healthcare standards.

Dormotech Medical is seeking a full-time, on-site Regulatory Specialist to join our growing team in Raanana.

The Regulatory Specialist will play a central role in supporting the company’s global regulatory strategy and international expansion activities across the United States, Europe, and Asia, with a strong focus on India and additional Asian markets.

Key responsibilities include:

• Supporting and maintaining FDA regulatory compliance and existing FDA clearances for Dormotech products
• Leading and supporting new regulatory submissions in India, Asia, and European markets
• Managing international product registrations and country-specific regulatory requirements
• Supporting CE MDR activities and global regulatory compliance processes
• Working with international distributors, regulatory consultants, and local representatives to support market access activities
• Monitoring changes in international medical device regulations and assessing their impact on company products
• Collaborating with R&D, Quality Assurance, Clinical, and Operations teams throughout the product lifecycle
• Managing technical documentation, regulatory files, labeling, and submission records
• Supporting regulatory strategies for innovative digital health and AI-based medical technologies

• Strong knowledge of medical device regulatory compliance and international regulatory requirements
• Proven experience in Regulatory Affairs, including regulatory submission preparation and management
• Experience with FDA regulatory pathways and maintenance of FDA-cleared medical devices
• Experience with regulatory submissions and registrations in India is required
• Familiarity with Asian medical device regulatory frameworks is highly preferred
• Experience with CE MDR and European regulatory processes is an advantage
• Strong analytical, organizational, and technical documentation skills
• Excellent written and verbal communication abilities
• Experience in digital health, physiological monitoring, sleep diagnostics, or medical device industries is an advantage
• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field
• Join Dormotech Medical and help shape the future of sleep diagnostics, neurophysiological monitoring, and AI-driven healthcare technologies.