Katalyst HealthCares & Life Sciences
Regulatory Affairs Associate
Katalyst HealthCares & Life Sciences, Chicago, Illinois, United States, 60290
Job Title
Responsibilities: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
Responsibilities: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.