The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Caption Health is at the forefront of bringing deep learning advances to critical unsolved healthcare problems.
Participate on project teams, providing regulatory strategy, timelines, and deliverables
Prepare or coordinate the preparation of pre-submissions, De Novo requests, 510(k) submissions, and Technical Files for CE marking
Work collaboratively with company engineers, provide informed, creative and effective solutions to the many challenges the design team faces in getting products through to commercial release
Review Change Orders and assess regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures
Review labeling and assess compliance against relevant regulations and product requirementsInterpret statutes, regulations, policies and guidances, communicating how these impact product development, manufacturing, and/or marketing
Develop and maintain regulatory affairs department procedures and process improvements
Bachelor's Degree in engineering, computer science, the natural or biological sciences, or equivalent
Excellent technical writing and communications skills with a highly analytical, detail-oriented approach to solving complex problems.
2+ years experience in regulatory affairs in the medical device industry preferred
Experience with Software as a Medical Device (SaMD), medical imaging, and cardiovascular devices a plus
Strong planning and organizational skillsStrong teamwork ethic, passion for learning and desire to seek new challenges
Internal Number: 1001
About Caption Health
Our vision is to move specialty diagnostics and decision-making to the point of care for every patient exam. Our AI software empowers healthcare providers with new capabilities to acquire and interpret ultrasound exams.
Caption AI, the first and only FDA authorized AI-guided medical imaging acquisition system, is now commercially available!