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.