Regulatory Affairs Specialist

Regulatory Affairs SpecialistCorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.The Regulatory Affairs Specialist will support the preparation, review, and submission of regulatory documentation for medical device/IVDs products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position focus on submitted documents preparing, helping to secure timely product approvals and regulatory clearances.Key ResponsibilitiesPrepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agenciesEnsure product compliance with FDA regulations, ISO 13485, and applicable international standardsWorking on analytical performance test with product development teams to draft documentation.Perform regulatory assessments for product changes and propose appropriate regulatory pathwaysMaintain documentation and records of all regulatory submissions and correspondenceSupport the preparation for regulatory agency meetings, audits, and inspections