מהנדס הבטחת איכות/רגולציה

Company Description
Allium Ltd develops, manufactures and sells globally innovative long-term, fully covered, expandable and retrievable stents for the treatment of the various obstructions in the urinary tract. Allium’s unique stent solutions are providing a minimally invasive, reversible alternative solution compared to the common practice of surgery or short time solutions. With the vast global proven experience and usage, Allium is paving the way for patients and physicians providing the next level of patient care.

Role Description
This is a full-time on-site role located in Caesarea for a Quality Assurance/Regulatory Engineer. The Quality Assurance/Regulatory Engineer will be responsible for ensuring compliance with all applicable regulatory and quality guidelines and submitting regulatory filings for product approval. They will also monitor and audit operations to ensure that quality standards are met, and will lead and participate in investigations, identify risks and opportunities for improvement.

Qualifications

• Bachelor's degree in Engineering, Regulatory Science, or a related field 2+ years of experience in Quality Assurance and/or Regulatory Affairs in the medical device industry
• Strong knowledge of FDA/EU/QSR regulations and guidelines
• Experience in filing 510(k) and CE mark submissions
• Strong analytical and problem-solving skills with the ability to manage multiple projects and priorities
• Excellent communication and interpersonal skills with the ability to work effectively both independently and as part of a cross-functional team
• Fluency in English, both written and verbal