A world renowned Class III Medical Device company is looking for a qualified Regulatory Affairs professional to join their Bay Area site as an Regulatory Affairs Manager.
~Manage regulatory team consisting of direct reports
~Lead all new product submissions (IDEs, 510(k)s, PMAs, etc.)
~Develop, plan and execute regulatory strategy to ensure approval/clearance in a timely manner
~Support cross-functional teams as needed
~Bachelor's Degree in a Life Science (MS/MBA/PhD preferential)
~5+ years experience within Regulatory Affairs in the Medical Device industry
~Class III Device experience and PMA submission experience
Sthree US is acting as an Employment Agency in relation to this vacancy.