Job requirements and application form

Manage and drive regulatory projects supporting the company’s product portfolio across global markets, ensuring alignment with regulatory requirements, timelines, and business objectives. Plan, coordinate, and execute regulatory submission activities for international regulatory authorities (including FDA, CE, and other applicable frameworks), including submissions for new products as well as changes to existing products. Oversee preparation and maintenance of regulatory documentation, including technical files, submission dossiers, and supporting materials required to obtain and sustain product approvals. Monitor regulatory requirements and updates, and translate them into actionable internal processes, project activities, and documentation updates to ensure ongoing compliance. Provide regulatory input throughout product development and for modifications to existing products, including review of design inputs and outputs. Coordinate cross-functionally with R&D, Quality, Clinical, and other stakeholders to support regulatory activities and product lifecycle needs. Manage regulatory aspects of product changes and support maintenance of existing registrations across global markets. Review labeling, promotional materials, and other product-related content to ensure compliance with applicable regulations and internal policies. Support development and maintenance of internal procedures (SOPs, work instructions) related to regulatory activities.

Bachelor’s degree in a relevant scientific or engineering discipline. At least 3 years of experience in Regulatory Affairs within a medical device company. Proven experience in global regulatory submissions (FDA, CE, and other international frameworks). Excellent organizational, communication, and coordination skills in a cross-functional environment. High level of analytical thinking, attention to detail, and ability to manage multiple priorities. Fluent English with excellent written communication skills. Location: Caesarea