we are 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.
This position is open to all candidates.