Labeling Specialist- P3

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