Tiffany Ramsey's Linkedin Analytics

With over 20 years of experience in regulatory affairs and quality management, I am passionate about ensuring the safety, efficacy, and compliance of biologics, medical devices, and laboratory testing products. I have extensive knowledge and skills in cellular therapy, blood banking, and tissue banking. As the Director of Global Regulatory Affairs at CooperSurgical, I led a team of regulatory professionals in developing and executing global regulatory strategies for the company's portfolio of products in the women's health and fertility markets. I also collaborated with internal and external stakeholders to facilitate product approvals, registrations, and submissions in various regions and countries. I am motivated by the mission of improving lives through innovative and high-quality solutions. Previously, I was the Director of Technical and Regulatory Affairs at GCAM, Inc., a leading plasma collection company that supplies high-quality plasma to Grifols, a global healthcare company. In this role, I was responsible for overseeing the technical and regulatory aspects of plasma collection, testing, storage, and release, as well as ensuring compliance with FDA, EMA, and other regulatory requirements. I also managed the implementation and maintenance of the quality management system, standard operating procedures, good laboratory practices, and continuous improvement initiatives. Additionally, I supported the business development and expansion of GCAM's plasma centers and laboratories across the US and internationally. Some of the skills that I utilized and enhanced in this role include risk management, audit preparation, root cause analysis, corrective and preventive actions, process validation, and data analysis.