Director, Regulatory Affairs

Define the strategic regulatory direction for pipeline development and global launch excellence. Serve as member of TECA+S RA LT, TECA+S PLTs, including Sports/Soft Tissue, Trauma, CMFT, Bio and Spine (as needed) PLTs. Partner with R&D and Global Strategic Marketing leaders as well as other functional leaders to develop and implement strategy for pipeline development and global launch excellence. Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit. Manage, oversee and balance resource allocation across critical projects. Lead and develop Regulatory staff to become future leaders. Partner with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations. Ensure company policies, procedures and practices are in compliance with appropriate regulatory requirements. Assure timely regulatory clearances for key product launches in all key markets. Requirements A minimum of a bachelor’s degree is required. An advanced degree is preferred. Minimum 10 years relevant / regulated industry experience is required. Previous experience with medical devices is required. Previous experience with biologics/biomaterials, digital, Class 3 implantable devices is preferred. Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required. Senior leadership experience is preferred, including line management of multiple levels of reporting. Experience working with professional and trade associations is a plus. May require up to 20% travel. Core Competencies Demonstrates expertise in developing and implementing global regulatory strategies for pipeline development and product launches, with a strong focus on compliance and leadership in the medical device and biologics sectors. #J-18808-Ljbffr