Regulatory Affairs Engineer - Israel

ART MEDICAL is a well-funded medical startup transforming ICU care through advanced technology and innovation. Our smART+™ platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition. Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days.

We are looking for an experienced Regulatory Affairs Engineer to join our team.
This is a temporary position for a period of 9-12 months, with an option to extend to permanent employment.

Role & Responsibilities

• Compile and maintain global technical and medical device files according to current standards and regulations
• Support to all areas of company activities related to regulatory requirements, including internal and external audits.
• Write or update standard operating procedures, work instructions, or policies that support regulatory activities.
• Participate in the ECO, CAPA, and MRB processes to identify regulatory needs.

Requirements

• BSc in Biomedical Engineering (or equivalent scientific degree).
• At least 3 years of experience in regulatory affairs in the medical devices industry.
•  English – Fluent reading and writing.
• Ability to multi-task, prioritize, be accurate, and be thorough.
• Ability to work under pressure and in tight schedules