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Regulatory & Quality Affairs Manager
Не указаноПолная занятостьMedical Devices
Lead global regulatory strategy and quality operations for Software as a Medical Device products used in AI-based medical imaging. Manage submissions, audits, quality systems, risk processes, and compliance throughout the product lifecycle.
Обязанности
- Lead regulatory submissions for SaMD products in the United States, European Union, Israel, and other international markets.
- Prepare, coordinate, track, and follow up on regulatory approvals.
- Lead regulatory and quality inspections and audits, including FDA, CE, third-party, and internal audits.
- Communicate with regulatory bodies.
- Develop annual quality plans and implement and maintain the quality management system.
- Collaborate with R&D, Quality, Clinical, Product, and Business teams across the product lifecycle.
- Prepare, review, and approve product development documentation, including requirements, risk analyses, and clinical validation protocols.
- Deliver internal training on global standards and regulations.
- Conduct management reviews and collect and analyze quality data.
- Manage the risk management process.
- Plan and implement company training required by the quality management system.
- Plan onboarding for new employees.
Требования
- At least 5 years of regulatory management experience in the medical device industry.
- Knowledge of United States, European, Israeli, and other international medical device regulations.
- Experience with Software as a Medical Device regulation, machine-learning software development lifecycles, and cybersecurity regulations.
- Experience preparing regulatory submission documentation, including 510(k) submissions and CE technical files.
- Experience implementing quality management systems compliant with FDA 21 CFR Part 820, ISO 13485, EU MDR, ISO 62304, and ISO 14971.
- Experience with regulatory activities related to clinical evaluation.
- Professional fluency in Hebrew and English.
- Experience leading people and cross-functional processes.
Будет плюсом
- ISO 13485 auditor certification