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. Role Description 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 Qualifications 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.

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