At Integra LifeSciences, I developed labeling for medical devices in accordance with FDA and EUMDR regulations, ISO requirements, and company work instructions. I created and revised instructions for use and other labeling for surgical and tissue technology devices.
At Philips, I created static and dynamic data labels for Image Guided Therapy diagnostic devices and prepared labeling packages for first article inspection. I worked with cross-functional teams to approve and release labeling through Windchill.
At Action Learning Systems, I created and produced training manuals for print and online use, along with marketing materials for educational programs. I also prepared press-ready files and managed inventory, packing, and shipping of materials.
Earlier, I wrote and edited operator's manuals for surgical laser systems at Coherent Medical Group/Lumenis Inc. I also developed website content and graphics, and created manuals in multiple languages with an outside translation vendor.
