דרושים Regulatory Affairs Engineer (Temporary position) בנתניה

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 approximately 6 months, with an option to extend to permanent employment.

As a Regulatory Affairs Engineer, you will:

• 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.
• Participation in the ECO, CAPA and MRB process for identifying 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.
• Experience as a QA Engineer in a Medical Device company - big advantage.
• Ability to multi-tasking, prioritizing, accuracy and thoroughness.
• Ability to work under pressure and in tight schedules.