Regulatory Affairs Engineer

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.

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 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-tasking, prioritizing, accuracy and thoroughness.
Ability to work under pressure and in tight schedules.