Denver, CO, 80238, USA
18 hours ago
Regulatory Labeling Specialist - INTL Costa Rica
Job Description A leading international medical device company is looking to add a Labeling Specialist to their Costa Rica site (San Filipo/San Francisco district). They are looking for someone to bring their passion and energy into a growing department dedicated to the quality output of product labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP’s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. You are responsible for: · Develop and maintain Instruction for Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy. · Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats. · Use of PLM (Windchill) for document control process to route all work for approval · Perform prepress activities necessary to prepare labeling artwork files for accurate output. · Prepare and route labeling packages for 1st article and approvals. · Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices which focuses on a first-time right approach. Attention to detail with minimal errors is key. · Reviews and updates as necessary to ensure proper revision control and storage of all labeling. · Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments. · Can successfully work with cross-functional teams to address NCRs and CAPAs. Investigate, analyze, and identify root cause. Evaluate underlying issue and find long-term solutions. · Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes. This role can pay between $15.00-20.00 USD per hour. This opening will be hybrid, with an expectation of in office work 3 days per week. This role is a 1 yearlong contract, with the possibility of extension or conversion 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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements - Bachelor's degree  - Labeling experience (more experience the better, at a minimum 2 years, understand UDI barcodes and dynamic data)  - Adobe Creative suite and Microsoft  - Excellent written and verbal communication skills  - Ability to organize and prioritize workflow  - Ability to work with all employees including cross-functional teams  - Strong attention to detail - Adobe Lifecycle  - Exposure to bartender, Enlabel, Windchill and/or SAP, Lifecycle  - Knowledge of regulatory standards * FDA, EU MDR, Japan, Canada, ISO
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