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Compliance & RA Analyst

Tel Aviv · Full-time

About The Position

Scopio Labs is transforming hematology and the process of cell morphology analysis. Scopio offers a suite of digital diagnostic applications and platforms that replace the manual microscope, enable dramatically faster, earlier detection and diagnosis of blood-related cancers, anemia, bacterial and viral infections, expediting access to life-saving treatments for better patient outcomes.



Scopio has developed a revolutionary digital imaging platform using novel computational photography. Built on top of this breakthrough technology is Scopio’s clinical-grade AI that automatically analyzes blood samples at the highest resolution in the world today within minutes. Scopio Labs has secured FDA clearance for its Full-Field Peripheral Blood Smear Application and its technology is in commercial use at hospitals and labs in the US, Europe, and Israel. 



We are looking for a Compliance & RA Analyst to join our Compliance and RA team. Scopio’s Compliance and RA team is responsible for the company’s regulatory activities, quality management system, and for ensuring compliance with applicable standards, including standards related to security and privacy. 


The team plays a central role in both pre-market and post market activities. The Compliance & RA analyst will take an important role in the company’s regulatory, quality and compliance activities, including – ensuring compliance with the relevant quality standards (including ISO 13485:2016 and 21 CFR 820); Supporting internal audits, corrective efforts and different quality projects, defining quality procedures, protocols and tools.

What you’ll be doing

  • Support the company’s regulatory activities – analyzing regulatory requirements, preparing regulatory submissions, and performing regulatory registrations;
  • Promote the company’s quality management system;
  • Collaborate with the different teams in Scopio in order to meet the relevant requirements;
  • Leading compliance related projects;
  • Define and maintain the Company’s Quality Management Systems;
  • Provide ongoing support to the company’s quality management activities;
  • Support R&D & Software life cycle management activities;
  • Maintenance of the Company’s QMS systems and platforms;
  • Analyze, identify, and investigate product issues

Requirements

·        Relevant Bachelor degree (Law, Industrial Engineering, Bio-technology Engineering, Life Science/ Exact Science)

·        Experience with medical device’s Regulatory Affairs (RA) – Advantage.

·        Understanding of Quality Assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar) – Advantage

·        Team player

·        Self-learner, highly motivated and independent individual

·        Excellent communication skills (both written and verbal)

·        Strong attention to details

·        English Proficiency

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