Nancy Morrison has over 25 years of experience dealing with FDA regulated products in the pharmaceutical and medical device industry on both the Quality Assurance and Regulatory Affairs sides. As a quality professional, she has implemented GMP, QSR, and ISO 13485 compliant quality systems and led successful audits by FDA, Health Canada, Notified Bodies, TTB (Alcohol and Tobacco Tax and Trade Bureau), and many customers. As a regulatory affairs professional, she has experience in the pharmaceutical, cosmetic, and medical device industries with successful IND, NDA Supplement, Special 510k and traditional 510k submissions in the US with corresponding submissions in Canada and creation of technical files and design dossiers for the EU. Additionally, she has RAC credentials through RAPS that span US and the EU, which has equipped her with the skills necessary to be successful on projects relating to EU medical device regulations, specifically, ISO 13485 certification, technical files, design dossiers and Clinical Evaluation Reports.
Nancy has a proven track record for managing complex regulatory and quality projects to successful conclusion while meeting tight budgets and timeline targets. She has the skill to balance regulatory requirements with business priorities to offer multiple solutions to best fit the situation, whether for a small startup or an established, multinational company. Rather than allowing regulations to limit possibilities for her clients, she has the unique ability to use them to identify opportunities, ensure compliant processes, and anticipate changing circumstances to enhance effectiveness. Nancy is a strong team player that deploys exceptional verbal and written communication skills to build collaborative, long-lasting relationships with stakeholders to ensure the success of every project, product and business.