Regulatory Affairs Specialist

Role Description

This is a full-time, on-site role for a Regulatory Affairs Specialist located in Raanana. The Regulatory Affairs Specialist will be responsible for creating and managing regulatory documentation, ensuring compliance with applicable regulations, and maintaining up-to-date knowledge of regulatory requirements. The specialist will coordinate regulatory submissions and maintain communication with regulatory authorities to facilitate approvals. Collaboration with cross-functional teams to ensure all processes meet regulatory standards will also be a key aspect of the role.

Qualifications

• Proficiency in Regulatory Documentation and preparing related technical files
• Strong understanding of Regulatory Compliance and adherence to applicable standards
• Knowledge of Regulatory Requirements in the medical or digital health industry
• Experience with Regulatory Affairs and managing processes in a regulated environment
• Familiarity with Regulatory Submissions, including liaising with regulatory authorities
• Exceptional organizational abilities and attention to detail
• Bachelor's degree in Life Sciences, Biomedical Engineering, or related field
• Experience in the medical device or digital health sector is a significant advantage