Technical Writer - III
- Heredia
- Permanente
- Tiempo completo
- 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.
- 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 for product 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.
- 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.
- 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.