Quality Engineer – Development & Regulatory

A global, stable, and technologically advanced medical device company is looking for a Quality Engineer – Development & Regulatory to join its team.

Location: Bar-Lev Industrial Park

Work Model: On-site, with the option for hybrid work – up to 2 days from home per week.

The position focuses on regulatory affairs, product registration and documentation, alongside active involvement in quality and product development processes throughout the product lifecycle.

Key Responsibilities:

• Lead regulatory registration and documentation processes for medical devices.

• Prepare regulatory documents, protocols, reports, and technical documentation.

• Support new product development processes from concept through transfer to production.

• Participate in Design Reviews and Design Control activities throughout the product lifecycle.

• Ensure compliance with ISO 13485, FDA, and MDR/CE requirements.

• Prepare, update, and maintain product files and engineering/regulatory documentation.

• Support engineering change processes, regulatory updates, and regulatory events.

• Lead CAPA processes, non-conformance investigations, and Root Cause Analysis.

• Work closely with R&D, Engineering, Quality, Regulatory Affairs, and Manufacturing teams.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a relevant field.

• 2+ years of experience in Quality and Regulatory Affairs within the medical device industry – mandatory.

• Significant experience in writing, preparing, and managing regulatory documents and protocols – mandatory.

• Strong knowledge of ISO 13485, FDA, and MDR/CE requirements.

• Experience working in medical device product development – a significant advantage.

• Experience with CAPA, risk analysis, and failure investigations – an advantage.

• Very high level of English – reading, writing, and speaking.

• Strong analytical skills, attention to detail, and excellent organizational abilities.

• Ability to work effectively with multiple interfaces and manage several tasks simultaneously.