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Sr. Director of Regulatory Affairs

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.

Responsibilities:

~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

Qualifications:

~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.