Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Regulatory Labeling and Publications Specialist for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.  

Position Description (Principle Duties and Responsibilities)

• Research, edit, and coordinate the release of all technical content and labeling specifications for medical devices (including user manuals, IFUs, quick start guides, device markings, package labels, artwork, and other user-facing documentation).
• Review product documentation and labeling against market regulations and industry performance standards to determine compliance and fitness for release to markets.
• Ensure that product literature and labeling is consistent, clear, technically accurate, complete, and meets regulatory, marketing, and branding requirements.
• Initiate the change order release of product documentation and labels using Agile.
• Organize and facilitate content and quality reviews of assigned user guides and Instructions for Use (IFUs).
• Research and update post-market changes to product labeling.
• Coordinate language translations of technical content and labels.
• Proven ability to work effectively in cross-functional teams.
• Understands labeling operations relevant to product packaging/manufacturing processes.
• Ensure that labeling artwork and proofs are accurate and meet all medical, legal, and Global regulatory requirements.
• Ensure regulatory compliance, accuracy, timely completion, and version control of all new and revised labels and IFUs.
• Strong organizational and follow-up skills, as well as attention to detail.

REQUIREMENTS:

• Bachelors' degree in a related field or an equivalent combination of education and work experience.
• Minimum 5 years experience in technical writing/editing.
• Minimum 2 years experience working with product labels, content management systems, and quality systems.
• Experience in EU MDR/FDA regulated industries strongly preferred.
• Experience in Microsoft Suite and Adobe Suite (Acrobat, InDesign, Illustrator, Photoshop).
• Experience in Agile (PLM), Arbortext, Prisym, CAD, and Creo a plus.