Regulatory Affairs & Quality Specialist

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Intelerad Medical Systems

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

501 - 1000

💰 $1.4M Venture Round on 2023-01

Description

• The Regulatory Affairs & Quality Specialist plays a crucial role within the Regulatory Affairs department. • This position is responsible for maintaining and improving certifications such as ISO 13485, MDSAP, and CE mark. • Ensures compliance with other relevant standards and regulations. • The Specialist collaborates with the Regulatory Affairs and Quality Manager to integrate regulatory requirements into processes and procedures. • Meanwhile, continuously enhance the management system. • This role also involves providing guidance, support, and training to the organization.

Requirements

• 3+ years of experience in quality management systems. • Bachelor’s degree in business, quality management, or related field (or equivalent). • Knowledge of ISO 13485, MDSAP, and EMDR requirements. • Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools). • Experience in the IT / software (SaaS) and/or medical device field (SaMD / SiMD) • Working knowledge of common security standards such as SOC 2 and ISO 27001 preferred. • Communication & Cognitive Abilities. • Process mapping and creation. • Autonomy and self-motivation. • Strong collaboration skills. • Problem-solving abilities. • Continuous learning mindset. • Effective communication skills – English fluency.