Labeling Specialist Consultant I
Oversee activities to complete sustaining product labeling changes, update labeling related SOP’s as needed, Strong understanding of labeling regulations and requirements, ability to project manage labeling projects, demonstrated ability to proactively manage product labeling needs for new product development and sustaining products, strong emphasis on exceeding customer expectations, while maximizing value to Hologic and maintaining FDA/ISO and other regulatory compliance.
Thorough understanding of US labeling regulations, Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label or in the labeling. Participate in project management meetings as needed. Review Document Change Orders for Regulatory compliance, including drawings and labeling changes. Support preparation (markup/annotate and clean) packaging components. Works with vendors/contractors to ensure adequate and timely support of SPL, compliance and proofreading activities.
• At least 3 –years labeling experience creating, editing and releasing product and packaging labels for medical devices;
• Must be fully conversant with different label creation tools such as bartender and loftware
• Must be fully conversant with UDI regulations and European Union label and symbol requirements
• Must be fully conversant with GS1-128 Labeling Formats
• Must have experience with supervising others and working with cross functional teams at multiple sites.
Description of Duties:
• Creation, editing and creating change orders for product and packaging labels including UDI barcodes in linear and 2D format.
• Working with manufacturing to set up printing formats based in Loftware or applicable printing software.
• Some travel will be required (approx. 15%) to work with the sites for inputs and peer review of the label content and printing files.
• Weekly progress reports will be required to the employee’s manager.
Thanks and Regards,
APN Software Services, Inc (www.apninc.com)
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-1080 / Fax 510-623-5055
Email Id: Sawant@apninc.com