Kristin McNamara is Senior Advisor to the Deputy Associate Commissioner for Regulatory Affairs in the Office of Regulatory Affairs (ORA) at FDA. She is on the FDA Case for Quality Steering Committee and works to provide strategic policy direction to FDA’s domestic and international product quality and safety efforts, helping coordinate a consistent agency response across ORA and CDRH to target those areas of greatest risk and ensure access to safe, effective and high-quality medical products.
Ms. McNamara has more than 15 years of government experience at FDA, NIH, State, EPA, OMB and Congress and 15 years of experience in the private sector, for non-profit organizations as well as state and local governments. She has served as an elected public official, as well as on several non-profit boards.
Ms. McNamara co-chairs the Medical Device Innovation Consortium Case for Quality Metrics Working Group with Marla Phillips.