<ul><li>Assist in preparing response to regulatory authorities questions within assigned timelines.</li><li>Stay abreast of regulatory procedures and changes in regulatory climate.&nbsp;</li><li>Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.&nbsp;</li><li>Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.&nbsp;</li><li>Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.&nbsp;</li><li>Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required.</li></ul><p><br>&nbsp;</p>

Manager-Regulatory Affairs (ROW Market)