I am a Regulatory Affairs Specialist with an RAC through Colorado State University (CSU) emphasizing medical devices, IVD, and human tissue. I also completed a CSU Project Management Certificate program.I love both people and new technology! I have a Biology degree and more than 15 years of experience in technical, regulated industries. My medical device regulatory compliance experience is with leading medical device companies: ConMed, Covidien, CR Bard, Medtronic, and Baxter Healthcare. At ConMed I manage orthopedic and general surgery registration projects. At Covidien I specialized in international submissions, UDI labeling and product rebranding with RMS and Surgical business units. At CR Bard I took responsibility for registrations for 61 countries during business integration and manufacturing transfer. At Medtronic Surgical Navigation I provided project coordination for harmonized symbols for labeling and international translations projects. At Baxter I implemented international regulatory document and labeling strategy during business integration with the new parent company. I have worked with R&D teams, and helped team members to handle regulatory details. I am familiar with design controls and product development processes. I have walked on the manufacturing floor. I have experience with rebranding, recalls, and audits.It is my nature to easily connect with people. I am thrilled to work with others who have a sense of urgency. I enjoy finding where the energy is building within a team that has a common goal such as getting a new product to market. I like to work with this energy. It is also a warm call for me to organize information and discuss priorities so that projects flow more easily. How can we move this forward? This is a question that I often has in mind.Specialties: International Regulatory Affairs. Medical Devices. Submissions. Regulatory Strategy. FDA Regulations. Technical Communications.
Listed skills include Medical Devices, Regulatory Affairs, Design Control, Iso 13485, and 46 others.
