Senior Director of Regulatory Affairs Management Hybrid working - some travel to Bay Area Medical Devices - Class III Competitive compensation + strong benefits Join a dynamic and innovative medical device company focused on developing Class III Medical Devices . We are looking for an experienced Senior Director of Regulatory Affairs to spearhead regulatory strategies and execution across the US. This is a hands-on leadership role ideal for an individual with extensive regulatory expertise in the US and a strong desire to mentor others, collaborate across functions, and drive innovation in a fast-paced, mission-driven environment. What You'll Be Responsible For: Leading a talented regulatory team in crafting and executing submission strategies (PMA, IDE, etc.) for Class III medical devices Overseeing regulatory planning and agency interactions (FDA, Notified Bodies, and international authorities) Collaborating with R&D, clinical, quality, and marketing teams to ensure global compliance Supporting audits and inspections while implementing proactive risk mitigation strategies Managing the regulatory compliance function and a product-focused Regulatory Affairs team Aligning regulatory activities with broader business and commercial priorities Who We Are Seeking: 10+ years of experience in regulatory affairs, preferably with Class III implantable devices Strong understanding of U.S. FDA regulations and regulatory submissions Proven experience with PMA/IDE submissions Proven leadership skills and strategic thinking ability Excellent communication skills with the ability to engage effectively with executives and regulators This is an exceptional opportunity to become a pivotal regulatory leader within a growing organization that is genuinely committed to improving lives. If you are passionate about making a difference, we encourage you to apply today! We are excited to connect with you for a discussion—this position will move to interview and offer by mid-October!