Senior Director, Global Regulatory Strategy (PMA/Class III)

EPM Scientific is partnering with a medical device leader to recruit a Senior Director of Regulatory Affairs in San Francisco. The role leads global regulatory strategy for high-risk Class III devices with PMA focus, coordinating FDA interactions and IDE planning.

The candidate will provide strategic guidance across clinical and regulatory requirements, build and mentor a regulatory team, and drive submissions worldwide while aligning with R&D, Quality, and Commercial teams.