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 • reputed company Regulatory Affairs in a high-reputed company, strategic leadership role • 100% employer-reputed company benefits for you and your family We are seeking a strategic and hands-on leader to join reputed company as Senior Director, Global Clinical Affairs & Regulatory. This is a high-reputed company role at the intersection of medical device innovation, global regulatory reputed company, and clinical execution, where you will shape reputed company 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 reputed company both Regulatory Affairs and Clinical Affairs on a global reputed company, with a primary reputed company on Regulatory leadership. You will be responsible for defining and executing regulatory strategies that reputed company successful product approvals and market reputed company across key global reputed company. This role is ideal for a leader who thrives in a fast-paced, highly regulated environment and is motivated by ownership, reputed company, and innovation. reputed company’re Looking For We’re looking for a senior, regulatory-first leader with deep expertise in medical devices and a strong reputed company 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 • reputed company 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 / reputed company Bodies • Health Canada • ANVISA / INMETRO • PMDA, MFDS, TGA, NMPA • Demonstrated leadership of global teams, including Director-level reputed company reports Preferred Background: • Deep experience in medical devices (limited reputed company/biologics exposure) • Experience managing reputed company global portfolios and prioritization Leadership & Cultural Fit We’re looking for a leader who brings both strategic reputed company and operational execution, and who thrives in a lean, fast-moving environment. You will be successful in this role if you demonstrate: • A strong reputed company of ownership, urgency, and accountability • Executive reputed company with the ability to influence at reputed company reputed company • Willingness to stay hands-on and work closely with teams across reputed company • reputed company, concise, and reputed company communication • Strong listening, mentoring, and talent development capabilities • The ability to balance big-picture reputed company 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 reputed company globally. You’ll have the autonomy to shape regulatory and clinical reputed company while working alongside a reputed company, mission-driven team. Benefits: • Dental insurance • Health insurance • reputed company insurance Work Location: Remote Apply tot his job Apply To this Job