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Labeling Specialist
1 month ago
Role Title: Labeling Specialist (Medical Device Industry)
Location: Irvine, CA, USA
Duration: Long-term Contract (W2)
Key Responsibilities:
- Develop, review, and update medical device labeling, including Instructions for Use (IFUs), product labels, and packaging artwork, in compliance with regulatory and company standards.
- Ensure labeling content aligns with applicable regulations such as FDA, EU MDR, ISO standards, and other global requirements.
- Collaborate with cross-functional teams (e.g., Regulatory Affairs, Quality, Marketing, R&D, and Manufacturing) to gather input and ensure accurate labeling content.
- Coordinate translations for global labeling needs, ensuring compliance with regional language requirements.
- Manage and maintain labeling documentation within document control systems to ensure traceability and version control.
- Conduct labeling risk assessments to identify potential compliance or user safety issues.
- Support audits and inspections by providing labeling-related documentation and addressing inquiries.
- Review and approve labeling changes through established change control processes (e.g., ECOs).
- Stay updated on regulatory changes and industry best practices to ensure ongoing compliance.
Qualifications:
Education:
- Bachelor's degree in Life Sciences, Engineering, Technical Writing, or a related field.
Experience:
- 2+ years of experience in labeling, technical writing, or a related role within the medical device, pharmaceutical, or healthcare industry.
- Strong understanding of regulatory requirements for labeling (e.g., FDA, ISO 15223-1, EU MDR).
Technical Skills:
- Proficiency in labeling and document management systems (e.g., Agile, Windchill, or PLM tools).
- Experience with graphic design tools (e.g., Adobe Illustrator, InDesign) is a plus.
- Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Soft Skills:
- Excellent attention to detail with strong proofreading and editing skills.
- Effective communication and collaboration skills to work across teams and regions.
- Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment.
