Main Duties: Successful Global Regulatory Submissions and Approvals, including 510(k)s and Technical Documentation Review by Notified Body in EU. Prepared product registrations for various countries and/or provided additional information to regulatory bodies for successful registration of products. Reviewed design and labeling changes to assess regulatory impact, filed various submissions and updates with regulatory agencies. Maintained up to date regulatory requirements for the business unit (Registrations/Regulatory Audits/Quality Manual/Quality System Certificates). Prepared and submitted 510(k)'s, IDEs, and other applicable product submissions according to FDA guidelines.
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