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.