Singapore, Singapore · On-site
Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA).Assist in ensuring compliance with app…
Skills: Regulatory Affairs, Quality Assurance, Product Registration, QMS Maintenance, ISO 13485
Alpharetta, Georgia, United States · On-site
Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countri…
Skills: E-commerce Strategy, Website Management, Digital Marketing, Amazon Storefront Management, Product Catalog Management
Atlanta, Georgia, United States · On-site
Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countri…
Skills: Procurement, Supply Chain Management, NetSuite ERP, Bilingual Chinese/English, Logistics Coordination
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Support regulatory submissions and product registrations for medical devices and IVDs with authorities like HSA, FDA, and EU IVDR. Maintain and improve the Quality Management System (QMS) while ensuring compliance through audits and documentation control.
Requires a Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field. Candidates must have at least 2 years of relevant experience in Regulatory Affairs or Quality Assurance within the medical device or IVD industry.
A global diagnostics organization delivering answers when you need them most.
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 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 disease such as COVID-19, pregnancy, drugs of 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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: 5900 Windward Pkwy W, Alpharetta, Georgia 30004, US · 9540 Waples St, Unit C, San Diego, California 92121, US · Beijing, 102433, CN · Dubai, AE
A global diagnostics organization delivering answers when you need them most.
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 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 disease such as COVID-19, pregnancy, drugs of 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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: 5900 Windward Pkwy W, Alpharetta, Georgia 30004, US · 9540 Waples St, Unit C, San Diego, California 92121, US · Beijing, 102433, CN · Dubai, AE
