Job Information
Insight Global Labeling Specialist in Irvine, California
Job Description
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.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
- 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. null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.