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Regulatory Affairs Engineer (Temporary position) at ART MEDICAL Ltd
Netanya, Center District, Israel -
Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Medical Devices, Technical Files, Audits, Standard Operating Procedures, Work Instructions, CAPA, ECO, Biomedical Engineering, Quality Assurance, Multi-tasking, Prioritizing, Accuracy, Thoroughness, Pressure Management, Tight Schedules

Industry

Medical Equipment Manufacturing

Description
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.
Responsibilities
As a Regulatory Affairs Engineer, you will compile and maintain global technical and medical device files according to current standards and regulations. You will also support all areas of company activities related to regulatory requirements, including internal and external audits.