Regulatory Affairs Specialist

We’re Hiring: Regulatory Affairs Specialist - Medical Devices

Location: Or Akiva

Full-Time | On-Site (Hybrid work not available)

A growing medical device company, developing and manufacturing an innovative vascular treatment product sold in dozens of countries worldwide, is looking for a Regulatory Affairs Specialist to join its team.

What You’ll Be Doing:

• Maintain and update the Technical File per regulatory requirements
• Conduct gap assessments for updated standards
• Manage customer complaints, including investigations, CAPA, and statistical analysis
• Lead regulatory aspects of change control processes
• Prepare documentation for product registrations worldwide
• Participate in risk assessments (e.g., FMEA) and document updates
• Support PMS & PMCF data collection and analysis
• Assist with incident reporting
• Support and accompany regulatory audits and inspections

What We’re Looking For:

• B.Sc. in Science or Engineering – Required, 🎓 M.Sc. – Preferred
• 3 years of experience in medical devices regulatory affairs –Required
• Fluent English – written and verbal
• Strong documentation and attention to detail
• Knowledge of ISO 13485 – Required

Proven experience with:

• Risk assessments (FMEA)
• IFU writing
• Regulatory submissions
• Technical File creation and maintenance