Sr. Regulatory Affairs Specialist

Job Purpose:

Position provides regulatory expertise for the Smiths Medical site based in St. Paul, Minnesota.  The incumbent will also be required to provide regulatory advice and assistance to other Smiths Medical site representatives.  This will require travel from time to time to effectively carry out these duties.  Prepare and submit regulatory submissions to Regulatory Authorities eg the FDA, for PMAA, IDE, 510k Notification and to European notified body to support distribution and marketing objective set by divisional and corporate staff. 

Duties:

Technical Knowledge and Skills: