Senior Labeling Specialist - P4

Responsibilities : Author physician and patient medical device product literature deliverables using Adobe InDesign. Manage, organize, and communicate project information and project activities cross-functionally. Represent the Technical Communications function within project core teams. Apply corporate and regulatory medical device Labeling requirements as it pertains to device product literature. Lead medical device literature standards and regulation projects, where a high level of medical device labeling regulation knowledge is required. Work with other technical communicators to organizing Instructions For Use (IFU) and related product literature for to support regulatory submissions, market expansion, and product commercialization targets. Interface cross-functionally within the product development teams to acquire source material for documents and to develop an understanding of BSC Neuromodulation device hardware and software products. Interface with, and participate in the management of, third party translation suppliers to ensure that global product literature content is translated accurate per schedule. Requirements 5+ years of experience working as a technical communicator creating product labeling literature (IFUs) within the medical device or pharmaceutical industry. Proficient in the use of Adobe InDesign and ability to demonstrate such proficiency. Demonstrated knowledge of Technical Writing principles and ability to demonstrate such proficiency. Demonstrated ability working under the guidance of standard operating procedures governing the development of medical device product labeling. Preferred Qualifications Bachelor's degree in Scientific and Technical Communications or similar Advanced degree in a health science or a scientific field of study Demonstrated knowledge of the FDA code of federal regulations 21CFR parts 820 and 801, as well as the EU MDR regulations governing medical device labeling. Experience working with medical device labeling translation suppliers, including authoring content for translatability. Requisition ID : 612524 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login / Register.