Based out of the Bay Area, an implantable Medical Device company is searching for a Sr. Director of RA to join their team. The role will have direct reports but will still be hands-on with submissions. They are offering a lucrative base salary + annual bonuses and stock options.
~Plan, initiate and lead global regulatory strategy
~Manage regulatory team; oversee all regulatory submissions through direct reports to ensure smooth approval, both original and supplemental (PMAs, 510(k)s, etc.)
~Support cross-functional teams throughout development of product
~Work directly with FDA and international regulatory bodies
~B.S. in Life Science or Engineering, M.S./PhD preferred
~10+ years Regulatory Affairs (Medical Device) experience
~3+ years managerial experience with multiple direct reports
~Implantable device experience - software/hardware experience preferred
Sthree US is acting as an Employment Agency in relation to this vacancy.