Support engineering with the generation, update and maintenance of technical documents.
Responsibilities:
physician and patient medical device product literature deliverables using Adobe InDesign.
Manage, organize, and communicate project information and project activitiescross-functionally.
Represent the Technical Communications function within project core teams.
Apply corporate and regulatory medical deviceLabeling requirements as it pertains to device product literature.
Work with other technical communicators to organize Instructions For Use (IFU) and related product literature to support regulatory submissions, market expansion, and product commercialization targets.
Interface cross-functionally within the product development teams to acquire source material forproduct literature, 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:
3+ years of experience working as a technical writer creating procedural-based instruction manuals.
Demonstrated knowledge of Technical Writing principles and ability to demonstrate such proficiency.
Demonstrated ability working under the guidance of standard operating procedures.
Demonstrated ability to understand complex information and explain it in a simplified manner.
Preferred Qualifications:
Bachelor degree in Scientific and Technical Communications or similar
Familiarity with the use of Adobe InDesign and ability to demonstrate basic proficiency.
Advanced degree in a health sciences 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.