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 devices
• Support new product development processes from concept through launch
• Prepare regulatory documentation, submissions, and maintain product regulatory files
• Work closely with R&D, Quality, Engineering, and Manufacturing teams to build effective regulatory strategies
• Assist with regulatory events, engineering changes, and standards updates

Requirements:

• Minimum 2 years of experience in regulatory affairs within the medical device industry – required
• Strong understanding of regulatory standards such as ISO 13485, FDA, and MDR
• Excellent English skills – professional reading, writing, and documentation
• Relevant academic background (Engineering, Life Sciences, Quality, or related field)
• Strong organizational skills with high attention to detail and the ability to collaborate across multiple functions
• Experience preparing regulatory submission documents – an advantage