Senior Director of Regulatory Affairs Hybrid working - some travel to Bay Area Medical Devices – Class III Competitive compensation + strong benefits

Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.

A growing medical device company developing Class III Medical Devices are seeking a Senior Director of Regulatory Affairs to lead strategy and execution across the US.

This is a hands on + leadership role; ideal for someone with deep regulatory knowledge in the US and a passion for mentorship, cross-functional collaboration, and innovation in a fast-paced, mission-driven environment.

What You’ll Be Doing: Lead a talented regulatory team in developing and executing submission strategies (PMA, IDE etc.) for class III medical devices Own regulatory planning and agency interactions (FDA, Notified Bodies, international authorities) Collaborate across R&D, clinical, quality, and marketing to ensure global compliance Support audits, inspections, and implement proactive risk mitigation strategies Manage regulatory compliance function and product-focussed RA team Influence the broader business by aligning regulatory activities with commercial priorities

Who We’re Looking For: 10+ years in regulatory affairs, ideally with some Class III implantable devices Strong working knowledge of U.S. FDA and regulatory submissions Experience with PMA/IDE submissions Proven team leader and strategic thinker Excellent communication skills, comfortable engaging with executives and regulators alike

This is a fantastic opportunity to be a key regulatory leader within a growing organization that's genuinely improving lives.

Apply today for a call back to discuss - this position will move to interview and offer in mid-October!