Katalyst Healthcares & Life Sciences
Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences, Richmond, Illinois, United States, 60071
Job Title
Responsibilities: Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Notifications. Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets. Interact with regulatory agency reviewers as well as distribution partners to facilitate...
Responsibilities: Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Notifications. Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets. Interact with regulatory agency reviewers as well as distribution partners to facilitate...