Regulatory Affairs Specialist

About UsCorDx, 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.Position SummaryThe 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 documentationPerform 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 inspectionsRequirementsEducation:Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field requiredLanguage:EnglishMandarin PreferredProfessional Experience:2-3 years of regulatory affairs experience within the medical device or IVD industryWorking knowledge of 510(k) submissions and regulatory documentation processesExperience interacting with FDA and other regulatory agencies preferredSkills & Competencies:Solid understanding of FDA regulations and Guidance. (510k, PMA, De novo)Strong organizational and project management skills with the ability to manage multiple projects and prioritiesExcellent communication, problem-solving, and attention to detailAbility to work collaboratively in cross-functional teams and manage document workflowsBenefitsComprehensive medical insurance401(k) plan with company contributionsFlexible paid time off (PTO) policy