Sr. Director, Global Affairs and Regulatory

• Join an innovative medical device company at the forefront of women’s health, pioneering cutting-edge technology that’s transforming patient care • Lead Regulatory Affairs in a high-impact, strategic leadership role • 100% employer-paid benefits for you and your family We are seeking a strategic and hands-on leader to join our team as Senior Director, Global Clinical Affairs & Regulatory. This is a high-impact role at the intersection of medical device innovation, global regulatory strategy, and clinical execution, where you will shape pathways that bring cutting-edge technologies to market worldwide. Location & Work Structure This role is U.S.-based remote. About the Role As a senior leader, you will oversee both Regulatory Affairs and Clinical Affairs on a global scale, with a primary focus on Regulatory leadership. You will be responsible for defining and executing regulatory strategies that enable successful product approvals and market access across key global regions. This role is ideal for a leader who thrives in a fast-paced, highly regulated environment and is motivated by ownership, impact, and innovation. What We’re Looking For We’re looking for a senior, regulatory-first leader with deep expertise in medical devices and a strong track record of ownership and execution. Required Experience: • 12–15+ years in the medical device industry (Class II/III strongly preferred) • Proven leadership of both Regulatory Affairs and Clinical Affairs, with Regulatory as the primary strength • Direct ownership of PMA and IDE strategies end-to-end (not just participation) • Experience in personally leading regulatory interactions and defending positions with agencies Strong background in global regulatory environments, including: • FDA • EU MDR / Notified Bodies • Health Canada • ANVISA / INMETRO • PMDA, MFDS, TGA, NMPA • Demonstrated leadership of global teams, including Director-level direct reports Preferred Background: • Deep experience in medical devices (limited pharma/biologics exposure) • Experience managing complex global portfolios and prioritization Leadership & Cultural Fit We’re looking for a leader who brings both strategic vision and operational execution, and who thrives in a lean, fast-moving environment. You will be successful in this role if you demonstrate: • A strong sense of ownership, urgency, and accountability • Executive presence with the ability to influence at all levels • Willingness to stay hands-on and work closely with teams across levels • Clear, concise, and collaborative communication • Strong listening, mentoring, and talent development capabilities • The ability to balance big-picture strategy with day-to-day execution Why Join Us? This is an opportunity to play a critical role in advancing innovative medical technologies that improve patient outcomes globally. You’ll have the autonomy to shape regulatory and clinical strategy while working alongside a collaborative, mission-driven team. Benefits: • Dental insurance • Health insurance • Vision insurance Work Location: Remote