Director, Regulatory Affairs

About Orthopaedics Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. We build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Role Overview The Director, Regulatory Affairs is responsible for setting regulatory strategy and driving excellence in product innovation, launch, and portfolio management for our orthopaedic devices and biologics. This role leads global regulatory strategy, oversees regulatory staff, partners with cross‑functional teams, and ensures timely regulatory clearances in key markets. Responsibilities Define the strategic regulatory direction for pipeline development and global launch excellence. Serve as a member of TECA+S RA LT and relevant PLTs (Sports/Soft Tissue, Trauma, CMFT, Bio, Spine). Partner with R&D, Global Strategic Marketing, and other functional leaders to develop and implement regulatory strategy. Exercise independent judgment to impact operational results, manage resource allocation, and oversee regulatory aspects of the product lifecycle. Lead and develop regulatory staff to foster future leadership. Monitor the global regulatory environment and assess impacts of new regulations on R&D programs. Deploy learning initiatives and training for cross‑functional partners on emerging regulatory requirements. Maintain coordinated communication with global and regional/local regulatory agencies. Ensure compliance with company policies, procedures, and regulatory requirements. Secure timely regulatory clearances for key product launches in all target markets, while assessing departmental structure and implementing strategic plans. Inspire and motivate regulatory associates and peers, communicating a clear vision. Identify and assess external innovation opportunities, including screening and technical due diligence. Represent the company’s strategic focus in internal and external forums and interactions. Apply strategic thinking to partner with senior stakeholders and influence decision‑making. Qualifications Minimum bachelor’s degree; advanced degree preferred. At least 10 years of regulated industry experience, with a proven track record in medical devices. Experience with biologics/biomaterials, digital, or Class III implantable devices preferred. Demonstrated ability to formulate global regulatory strategies aligned with business objectives. Senior leadership experience, including management of multiple reporting levels. Experience working with professional and trade associations is a plus. Willingness to travel up to 20% of the time. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans, individuals with disabilities, and are committed to an inclusive interview process. #J-18808-Ljbffr