IDx is looking for a highly driven, detail-oriented individual to help manage our quality assurance and regulatory compliance efforts. Working in a team setting, the candidate will lead development, implementation, and maintenance of the company’s quality systems and policies. They will also have an opportunity to understand – and, in some cases, help to inform the development of – the regulatory and legal process for clearing start-of-the art software devices through FDA and other government bodies. By understanding, communicating, training, and enforcing compliance standards, our Quality and Regulatory Affairs Manager will help accomplish IDx’s core quality assurance and business objectives.
This particular role requires affinity with quality assurance and ISO-standard/FDA compliance, or work in a similarly detail-oriented field. IDx operates within the regulated medical device industry and is following a highly structured development process that requires extensive documentation and record keeping.
What will help you in this role:
Experience with CE certification and FDA clearance, US and international medical device and data privacy regulations, and Quality Management System maintenance, including complaint handling, CAPA investigations, and internal audits.
The rigors and challenges of work at IDx are not for everyone, but the team here has some amazing opportunities to:
Build upon regulatory precedent to revolutionize health tech.
Tackle complex problems/projects with the highest levels of quality and execution for audiences that include top technologists, the FDA, and world-leading healthcare providers.
Push the accessibility and quality of healthcare to new heights to improve the lives of millions of people.
Bachelor’s degree or higher
Experience working with complicated regulatory standards or direct work experience in a strictly regulated industry such as medicine, aerospace, automotive, or legal
Exceptional analytical and organization abilities
Ability to derive joy from navigating complicated regulatory frameworks
Obsessive attention to detail
Genuine commitment to team work in a fast-paced, entrepreneurial environment
Desire to own decisions and take responsibility for outcomes
Strong verbal and written communication skills
Additional Salary Information: Based on experience
Internal Number: 102018
About IDx Technologies Inc.
IDx is a leading AI diagnostics company on a mission to transform the quality, accessibility, and affordability of healthcare. Founded in 2010 by a team of world-renowned clinician scientists, the company is focused on developing clinically-aligned autonomous AI systems that detect disease in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.
The company’s first product, IDx-DR, is an FDA de novo authorized AI-based diagnostic system designed for use at the front lines of care to detect diabetic retinopathy. IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400, an easy to use and highly accurate robotic fundus camera.
IDx is developing additional AI-based diagnostic systems for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease, and stroke risk.