Regulatory & Quality Affairs Manager

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.

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.

Requirements:

· At least 5 years of experience in RA/QA Manager position in the medical device industry, with knowledge of US, European, Israeli AMAR, and international medical device regulation

· At least 5 years of experience in Quality Assurance positions in the medical device industry, with knowledge in QMS implementation that complies with FDA 21 CFR Part 820, European Medical Device Regulation (MDR), ISO 13485, ISO 62304 and ISO 14971 standards.

· Experience with software medical device (SaMD) regulation – a must.

· Experience in in team or cross-functional teams leadership.

· Experience in preparing documentation for regulatory submissions (510(k), CE technical files).

· Knowledge of Quality System Requirements and Standards.

· A formal degree in engineering or science discipline

· Certified ISO 13485 Auditor- an advantage

· Ability to perform well in a fast-paced startup environment.

· Self-driven, communicative, detail oriented, and excellent interpersonal skills and attitude.

· Excellent written and verbal communication skills: Hebrew and English.

· Able to produce positive results with a strong sense of urgency and ability to multitask.

Responsibilities:

· Lead the QA/RA inspections in preparing, coordinating, tracking, and following up on approvals for medical device submissions including US 510(k), EU technical files, Israel, New Zealand, Thailand and more, as applicable.

· Research, plan, prepare, and obtain approvals for medical device submissions in growing global markets.

· Responsible for leading and coordinating both Quality and Regulatory inspections and audits, including preparation for company external audits by 3rd parties (CE and FDA) to ensure full compliance.

· 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.

· Works closely as key team members along with R&D, Quality, Clinical, Product management and Business on all aspects of product life cycle.

· Represent Regulatory Affairs on change controls and provide comprehensive regulatory assessments to support product and process modifications.

· Review and approve marketing communication materials.

· Act as liaison for communication with regulatory authorities or distributors regarding the company’s regulatory filings.

· Remain current developments in field(s) of expertise, regulatory requirements, and industry trends.

· Develop Annual Quality Planning , administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.

· Review, approve and execute all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments etc.

· Continuous improvement of Quality Assurance processes and procedures.

· Responsible for Annual Internal Audits, planning and implementation

· Establishing Quality Objectives based on KPIs (Key Performance Indicators )

· Root cause analysis and implementation of corrective action for process related concerns.

· Analyze failures, corrective and preventive actions to respond to internal/external customer complaints.

· Support the quality inspections to ensure projects, products and processes comply with the relevant requirements of the QMS

· Planning Company Training and implementation as required by the Quality management system

· Planning of new employees Onboarding

· Responsible for communicating with notified bodies regarding quality related issues

· Conducting management reviews, collection and data analysis

· Management of the Risk Management process

· Implementing and maintaining the Quality Management System (QMS), that complies with ISO 13485:2016, FDA 21 CFR Part 820, ISO 27001, GDPR, HIPAA.