Director of Regulatory Affairs (Fremont)

Senior Director of Regulatory Affairs

Hybrid working - some travel to Bay Area

Medical Devices Class III

Competitive compensation + strong benefits

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 Youll 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 Were Looking For :

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!