Katalyst Healthcares & Life Sciences
Global Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences, San Diego, California, United States, 92101
Job Title
Responsibilities: Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets. Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Notifications. Interact with regulatory agency reviewers as well as distribution partners to facilitate...
Responsibilities: Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets. Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Notifications. Interact with regulatory agency reviewers as well as distribution partners to facilitate...