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A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

We are hiring a senior data scientist to join Nucleai’s data science team. A cancer patient wants to know that their diagnosis and treatment are determined with the greatest precision and preferably using the most advanced technology. At Nucleai, we bring cancer patients cutting-edge AI-based technology by improving biopsy interpretation with machine learning and creating novel precision medicine technology. Come join our team of experienced AI engineers and world-renowned clinicians, and help us make a difference. At Nucleai, we believe that talents are our most valued asset, and as such, hiring the right people is one of our most strategic missions.
Position Overview The data science team provides the bottom line to our customers – which patients are the best fit for a cancer treatment and what is the chance of success. We do it by analyzing medical images and clinical data, researching spatial features, developing predictive models and applying statistical methods to evaluate the results. We work together with subject-matter experts, from medical doctors to software engineers, to leverage computer vision, focus on the most promising biological hypotheses and to productionize our capabilities.
Responsibilities:
* Independently lead the data science perspective in any project or assignment – from data mining, through developing new algorithms, to analyzing results and providing professional insights and guidelines.
* Contribute to the team's internal codebase with high-quality code and development standards.
* Augment our knowledge and best practices, adopt relevant SOTA data science methods and practices.
* Work closely with medical doctors, product and project managers, research scientists and software developers to focus your efforts, build new capabilities and provide value to your colleagues and our customers.