Company DescriptionAstute 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 DescriptionThis 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.QualificationsExpertise in Quality Assurance (QA) and Quality Management Systems (QMS), including ISO 13485 and FDA regulationsStrong understanding of Regulatory Affairs, including submission preparation, compliance monitoring, and global regulatory requirementsKnowledge of risk management principles and practices in medical devices or healthcare ITProficiency in technical documentation, audits, and regulatory reportingStrong analytical, organizational, and problem-solving skillsExperience in healthcare IT or AI-driven technologies is a plusBachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field; advanced degrees or certifications (e.g., RAC) are advantageousExceptional written and verbal communication skillsAbility to work independently and contribute effectively in a remote setting