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Astute Imaging is a healthcare IT company specializing in developing innovative AI-driven solutions for image-guided therapy and procedure planning. The company’s offerings include advanced cloud-based AI technologies tailored for medical device companies, enabling efficient product development, seamless pre-market approvals, and effective post-market surveillance. Astute Imaging is committed to advancing healthcare technology to improve patient outcomes and streamline clinical workflows.
Role Description
This is a full-time remote role for a Senior Quality/Regulatory Officer. The role involves overseeing quality assurance processes, ensuring compliance with regulatory standards, and maintaining accurate documentation for audits and certifications. Key responsibilities include developing regulatory strategies, managing submissions, monitoring regulatory changes, and implementing quality management systems. The officer will collaborate with cross-functional teams to ensure the organization’s products and operations meet relevant industry standards.
Qualifications
Expertise in Quality Assurance (QA) and Quality Management Systems (QMS), including ISO 13485 and FDA regulations
Strong understanding of Regulatory Affairs, including submission preparation, compliance monitoring, and global regulatory requirements
Knowledge of risk management principles and practices in medical devices or healthcare IT
Proficiency in technical documentation, audits, and regulatory reporting
Strong analytical, organizational, and problem-solving skills
Experience in healthcare IT or AI-driven technologies is a plus
Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field; advanced degrees or certifications (e.g., RAC) are advantageous
Exceptional written and verbal communication skills
Ability to work independently and contribute effectively in a remote setting
