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Assist in preparing, creation and maintenance regulatory documentation for FDA and CE submissions. Flexible working hours to accommodate academic schedules. Opportunity to gain hands-on experience in the medical device regulatory field.

we are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures.= We are seeking a skilled and detail-oriented QA Engineer to join our team. The ideal candidate will be responsible for executing Quality Assurance activities, managing quality projects, and participating in process and product validations to ensure compliance with established standards and regulatory requirements. The QA Engineer will work closely with cross-functional teams to support quality projects, provide manufacturing support, and drive continuous improvement initiatives across the organization. LOCATION: Yokneam, Israel. The position includes the following responsibilities: SCOPE & RESPONSIBILITIES Manage ECOs: conduct risk assessment, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. Manage DCOs in the PLM system : Write and update QA procedures to ensure compliance with quality standards and regulatory requirements. Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. Manage QA production activities: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. Ensuring Timely Resolution of Quality Issues: Promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. Participate in audits: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP requirements.

A fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global and every individual at is part of a life-saving mission.
About our technology
developed a digital imaging platform using novel computational photography. Built on top of this breakthrough technology is clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. has secured FDA clearance for its Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application and its technology is in commercial use at hospitals and labs in the US, Europe, and Israel.
About the position
We are seeking an experienced and dynamic Clinical Affairs Team Lead to join our growing company. This role is pivotal in ensuring successful execution of our clinical trial portfolio and alignment with regulatory and business objectives. The ideal candidate will have proven managerial and operational expertise in clinical trial execution and team leadership, coupled with a strong scientific background. This is an opportunity to lead a dedicated team and contribute directly to the success of the business.

What youll be doing
Clinical Trial Management: Lead and oversee the execution of multiple ongoing clinical trials, secure the successful completion of studies, and meet timelines and quality standards
Operational Excellence: Develop and optimize clinical trial processes, ensuring efficient workflows and compliance with regulatory standards
Stakeholder Collaboration: Act as the primary liaison between internal teams, external partners, and clinical sites to ensure alignment and effective communication
Regulatory Compliance: Ensure all clinical activities adhere to regulatory requirements, including those of FDA, CE, and other relevant authorities
Data Integrity: Oversee data collection, management, and reporting to ensure accuracy and reliability in support of regulatory submissions and business goals
Risk Management: Identify potential challenges and proactively implement solutions to mitigate risks to clinical trial success
Strategic Planning: Contribute to the development and execution of the clinical strategy in alignment with the companys goals and assume responsibility for clinical study design