Additional Locations: N/A
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: 612525