AMVETS Jobs

Job Title: Senior Product Labeling Specialist Req ID: 40770 Job Category: Engineering Mentor, OH, US, 44060 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary As a Sr. Product Labeling Specialist, you will work within Product Engineering with the crucial responsibility for the design, development, approval, and implementation of all product labelling on new and sustaining projects. This position is considered a Hybrid role - Minimum 4 days onsite at our Mentor, Ohio Headquarters is required. Duties You will interface with domestic and international Regulatory Affairs, Quality, Product Managers, New Product Development, Clinical Affairs, Purchasing, Manufacturing/Production, Information Technology, and Packaging Engineering and will be responsible for the labelling management for STERIS Endoscopy - Mentor, OH. In this role you will work closely with Regulatory Affairs to ensure compliance with domestic and international regulations. Additionally, the position includes working with multiple vendors (including translation services and print suppliers) and program management for all labelling projects. Other responsibilities include: Createand modifylabels, product instruction for use (IFU) documents, label cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines, and branding guidelines. Controland managenumerous product labeling project tasks that culminate in release to production via the engineering change process. Leadactivities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process and provides direction on the label management processes. Monitorchanges in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements. Conferwith label change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective, and timely manner ensuring all requested projects are planned and prioritized appropriately to meet project goals. Contributeto the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvements, country-specific requirements, labeling standards and regulations, and labeling stakeholders. Interfacewith other Labeling Specialists at STERIS especially with the Conroe, TX team to ensure processes and requirements are aligned. Workwith outside vendors on content translations for labels and IFUs. Demonstrateexcellent technical expertise of STERIS products and technologies, product labeling, and engineering change processes. Workwith IT, manufacturing, and document control personnel to set label printer parameters. Workwith this same team to troubleshoot issues and establish processes that eliminate issues. Required Experience Bachelor's degree, in science or communication related field. Minimum of 3 years product labeling experience for medical device or other regulated industry. Minimum of 3 years' experience and proficiency with common content management tools and systems - NiceLabel and NiceLabel Cloud preferred. Minimum of 3 years' experience with Regulatory requirements. Proficiency with common content management tools and systems. Experience with document management systems (PLM) Technical writing proficiency highly desirable with emphasis on medical device product labeling developmen