We are currently looking to add a Senior Labeling Specialist to our team in St. Cloud, MN. In this role, you will be responsible for developing and implementing Medical Device labels IFUs, and SDS content in support of new product development, product support, product registrations, quality-related labeling issues, business initiatives, and compliance activities. Coordinates with various functions on content development, global regulatory requirements, and operational tasks related to the design, development, implementation, review, and approval of all labeling. Assess impact of new and revised label regulations and generates gap assessments and develop quality plans.What can I expect in this role?In this position, you will work Monday Friday 8am 4:30 pm.Some key duties in this role include:Leads labeling and IFU activities in support of cross-functional projects, e.g. new product launches, new market expansion, on-market changes, etc. Creating and updating current labels for both packing product labels, from design elements perspective and adding symbols, content translations, and different design elements; branding with internal systems and reviewing process. Owns change control of changes to product labeling, IFUs, and SDSs. Provides support to R&D for implementation of labeling, SDSs and IFUs for new product development. Author new IFUs and SDSs for new products. Monitor new and upcoming changes to label regulations and standards. Performs gap assessments for changes in regulations and standards and develop quality plans to maintain compliance with global label regulations. Select, implement and manage labeling software. Coordinate with operations to implement labeling changes when needed. Including managing inventory depletion. Develop and manage procedures for labeling and IFUs. Manage translations of IFUs, SDSs and when applicable other labeling. Maintain UDI compliance for all countries including US, EU and ROW. Ensure accuracy of all labeling information. Support customer enquiries applicable to labelling. Support labelling implementation and printing at the factory and supplier level by ensuring assigned artwork is available and in usable formats Provide support to production and distribution sites regarding labelling artwork availability and content management.What makes you a good fit?Our goal is finding the right individual for our team we firmly believe that the right person is someone to invest in and invite to join our family.Here is what we are looking for:Four year technical degree required. 3-5 years previous medical device labeling experience required. Experienced in international medical device regulations including FDA, IVDR (or MDR), MDSAP and IMDRF. Experienced in global medical device UDI requirements including GUIDID and EUDAMED preferred. Experience with global labeling standards and symbols. Including requirements for hazardous materials. Experience using desktop publishing and typesetting tools such as Adobe Creative Cloud - Illustrator and InDesign preferred. The ability to pass a background check and drug screening.Who is Microbiologics?Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the worlds leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that 'great vision without great people is irrelevant.' That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.What can we offer you?Glad you asked!We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few. In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth.If you have a passion for science, we encourage you to apply!
