Katalyst HealthCares & Life Sciences
Regulatory Affairs Specialist-II
Katalyst HealthCares & Life Sciences, Okemos, Michigan, United States, 48864
Job Title
Responsibilities: Regulatory Affairs Specialist II provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Lead and Support US 510K Submissions. Lead and Support Health Canada Device License Applications. Lead and Support Self Certified and Notified Body Reviewed EU Technical File Pre...
Responsibilities: Regulatory Affairs Specialist II provides pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies. Lead and Support US 510K Submissions. Lead and Support Health Canada Device License Applications. Lead and Support Self Certified and Notified Body Reviewed EU Technical File Pre...