Regulatory & Quality Affairs Manager

Description:

Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. We develop AI-driven solutions to target highly prevalent chronic and acute diseases affecting large populations worldwide. Our technology analyzes routine medical CT scans for any clinical indication, helping identify patients with asymptomatic or undetected findings correlated with chronic conditions in cardiac, liver, and bone. By leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed.

If you want to be part of the revolution in medical imaging, make an impact and help shape a healthier future for all, join us! Being a Nanoxer means becoming part of a pioneering team that’s transforming the future of healthcare. You’ll work on breakthrough imaging technology that makes high-quality medical imaging accessible and affordable to billions of people worldwide. You’ll thrive in an innovative environment, pushing the boundaries of technology and AI to drive the transition to preventive healthcare. Experience growth in a fast-paced, dynamic setting, working alongside passionate professionals who value your ideas. Get hands-on with cutting-edge technology and AI, making a lasting impact on global healthcare. Our innovative environment encourages creativity and collaboration, offering you the chance to grow professionally while making a meaningful impact on global health. Together, we create extraordinary solutions. Shape your career and the future of medical imaging with us.

We are looking for a highly motivated Regulatory & Quality Affairs Manager to lead the company’s global regulatory strategy and quality operations. This pivotal role ensures that our Software as a Medical Device (SaMD) products meet international regulatory requirements and adhere to the highest quality standards throughout the product lifecycle - from design and development to post-market surveillance.

• Lead RA/QA in SaMD device submissions, US 510 (k), CE (EU-MDR), and other growing global markets. Including preparing, coordinating, tracking, and following up on approvals. 
• Responsible for leading and coordinating both Regulatory and Quality inspections and audits, including preparation for company external audits by 3rd parties (CE and FDA) as well as internal audits, to ensure full compliance.
• Responsible for communicating with regulatory bodies.
• Developing Annual Quality Planning, including implementing and maintaining the Quality Management System (QMS), that complies with ISO 13485:2016, FDA 21 CFR Part 820, ISO 27001, GDPR, HIPAA.
• Works closely as key team members along with R&D, Quality, Clinical, Product Management, and Business on all aspects of product life cycle.
• Prepare, review and approve product development documents, including test product requirements, risk analysis documents, clinical validation protocols etc.
• Provides internal training on understanding, interpretation, and implementation of global standards and regulations.
• Conducting management reviews, collection, and data analysis. 
• Management of the Risk Management process. 
• Planning Company Training and implementation as required by the Quality management system. 
• Planning of new employee onboarding.

• At least 5 years of experience as a Regulatory Manager in the medical device industry, with knowledge of US, European, Israeli, and other international regulations.
• Experience with SaMD regulation, specifically in working with SDLC with Machine Learning, including cybersecurity regulations
• Experience in leading, preparing, and writing documentation for regulatory submissions (510(k), CE Technical File).
• Certified ISO 13485 Auditor- an advantage
• Experience in Quality Assurance positions in the medical device industry, with knowledge in QMS implementation in compliance with FDA 21 CFR Part 820, ISO 13485, European Medical Device Regulation (EU MDR), ISO 62304 and ISO 14971 standards.
• Experience in Regulatory Tasks surrounding Clinical Evaluation
• Experience in leading people and driving cross-functional processes, with the ability to manage priorities and ensure successful execution.
• Excellent written and verbal communication skills: Hebrew and English.
• Ability to perform well in a fast-paced startup environment.
• Self-driven, communicative, detail-oriented, and excellent interpersonal skills and attitude.
• Ability to produce positive results with a strong sense of urgency and ability to multitask.