Regulatory Affairs Specialist

A successful, global, and rapidly growing medical device company is seeking a Regulatory Affairs Specialist to join its team.This is a full-time, on-site position located in Bar-Lev Industrial Park.The role offers an opportunity to take part in end-to-end regulatory processes within an innovative and stable organization.Key Responsibilities:Ensure compliance with international regulatory requirements for medical devicesSupport new product development processes from concept through launchPrepare regulatory documentation, submissions, and maintain product regulatory filesWork closely with R&D, Quality, Engineering, and Manufacturing teams to build effective regulatory strategiesAssist with regulatory events, engineering changes, and standards updatesRequirements:Minimum 2 years of experience in regulatory affairs within the medical device industry – requiredStrong understanding of regulatory standards such as ISO 13485, FDA, and MDRExcellent English skills – professional reading, writing, and documentationRelevant academic background (Engineering, Life Sciences, Quality, or related field)Strong organizational skills with high attention to detail and the ability to collaborate across multiple functionsExperience preparing regulatory submission documents – an advantage