Patricia K.

Hello, I'm Tricia, a highly skilled and strategic Regulatory Affairs Specialist. I bring extensive expertise in U.S. and global medical device regulations with a proven track record of success. My specialization lies in navigating the complexities of US regulatory affairs and in preparing and submitting 510(k) applications with a high success rate. With years of experience in managing regulatory documents, developing effective strategies, and liaising with both clients and the FDA, I excel in driving successful product approvals for a diverse range of medical devices, from Class I to Class III. I am known for my exceptional analytical, research, and critical thinking skills, which enable me to deliver clear, compliant, and innovative solutions to regulatory challenges. My ability to understand client needs, collaborate with cross-functional teams, and maintain strong communication with regulatory bodies has been key to securing approvals for innovative and complex devices. Whether guiding new product development or managing sustaining activities, I am committed to ensuring the success of each project by staying ahead of evolving regulations and maintaining a high level of productivity and efficiency. Core Competencies Include: ▪ U.S. and Global Regulations ▪ Submissions to Regulatory Agencies: 510(k)s, PMAs, IDEs, Pre-Submissions, and CERs ▪ Class I, II and Class III Devices ▪ Complex Submissions ▪ Regulatory Strategy and Implementation ▪ Project Management ▪ Effective Collaboration with Client, FDA and Internal Team ▪ Innovative Thinking and Problem Solving