Regulatory Affairs - Quality Manager

3 days ago

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Intelerad Medical Systems

WebsiteLinkedInAll Job Openings

medical imaging • distributed radiology solutions • distributed architecture & workflow orchestration • radiology • Enterprise Workflow

501 - 1000 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

💰 $1.4M Venture Round on 2023-01

Description

• The Regulatory Affairs & Quality Manager plays a crucial role within the Regulatory Affairs department. • This position is responsible for maintaining and improving certifications such as ISO 13485, as well as other relevant standards and regulations. • The manager will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. • Additionally, the manager will report to senior management on the status of ISO systems and certifications.

Requirements

• 3+ years of medical device regulatory experience required; SaMD a plus • Bachelor's degree in business, quality management, or a related field (or equivalent) • Knowledge of ISO 13485, ISO 9001, and/or ISO 27001 standards • Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools) • Strong verbal and written communication skills in English • Experience in the IT and/or medical device field • Process mapping and creation • Ability to work autonomously • Strong collaboration skills • Problem-solving abilities • Continuous learning mindset • Experience owning deliverables, project management, and/or team leadership experience nice to have