A medical device company is looking for a labeling specialist to join the team. As a labeling manager, you collaborate with graphics and translations suppliers to create accurate artwork and associated documentation for labeling. Your focus includes ensuring compliance with medical, legal, and global regulatory requirements. You oversee the timely completion and version control of new and revised labeling, updating product structure and work instruction documents as needed. Coordinating labeling changes, you meet established deadlines for regulatory submissions, production, and product launches. Additionally, you serve as the central communication hub for labeling information, providing guidance on pre-printed or CGL labels, translations, and specific regional requirements. Your role involves working closely with cross-functional teams to identify and address potential labeling issues, manage procurement, and maintain barcode processes related to product labeling. Key performance indicators emphasize 100% accuracy in artwork and labeling, supporting submission and production schedules. You also handle special projects, including training, process improvements, and procedure development. This role is a contract to hire, onsite in Irvine, CA or Santa Rosa, CA. Traveling between sites will be required.
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- 3 + years of product labeling experience.
- 5+ years combined experience in the pharmaceutical, biologics or medical device industries
- Thorough understanding of global product labeling regulations and regulatory processes
- Proficiency in Microsoft Word, Excel, and Adobe Acrobat
- Demonstrated expertise in managing the labeling content business process, including change control; knowledge of labeling content across all company products.
- Experience in cGMP/GDP/GCP (regulatory environments) environments, packaging, and FDA regulated industries strongly preferred.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.