Device Labeling Specialist
4 days ago
We are seeking a highly skilled Device Labeling Specialist to join our team at BRIOHEALTH SOLUTIONS INC. This is an exciting opportunity to work on the development of technical documentation for our BrioVAD implantable blood pump and related mechanical circulatory support technologies.
About the Role:This role requires a strong understanding of IFU and label development, change management systems, labeling systems, and medical device regulations (e.g., US, EU, Japan). As a Device Labeling Specialist, you will be responsible for creating high-quality labeling that complies with global regulations and standards. You will collaborate with cross-functional teams, including Clinical, Education and Training, R&D, Regulatory, Quality, Operations, and IT, to develop labeling that meets regulatory requirements.
Key Responsibilities:- Edit text for spelling, grammar, style, and general clarity, reviewing graphics for accuracy, correct positioning, and layout.
- Optimize content organization and ensure consistency in tone and presentation, identifying problematic usage of grammar, punctuation, abbreviations, and terminology.
- Incorporate all required changes for a product release and document reasons and justifications for each change.
- Work with vendors and suppliers of services to ensure high quality and accuracy of content.
- Provide support during internal and external audits and reviews.
- Bachelor's degree in a technical area with a minimum of 1 year of experience in a labeling capacity, or 2+ years of equivalent experience in a related engineering/regulatory role in a device industry.
- Ability to build strong relationships and work effectively with cross-functional team members.
- Proficient in the use of IFU and labeling software (e.g., InDesign, FrameMaker, Prisym, Loftware, ROBAR, IQVIA, Qarad).
- Possess an understanding of relevant medical devices and their use relating to labeling, design change control, and document control and management.
The estimated salary for this position is $90,000 - $120,000 per year, depending on experience. Our company offers a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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