Responsible for the effective collaboration and indication of finished goods product label content and IFU (instructions for use) content, in compliance with applicable regulations and Hollister Incorporated labeling policies and procedures. This position will oversee the development and revision of product labels for all Hollister Incorporated brand products to ensure continued compliance with regulations in the markets served, to support user needs, as well as to reflect the Hollister Incorporated Mission and Values.
This position is the company’s medical device product label regulation and requirements SME; owning and maintaining the Essential Labeling Elements spreadsheet that contains regulated medical device label data/content requirements per country/region government/agencies. This position requires an in-depth understanding of medical device labeling development and associated change management and labeling systems. This position must have the ability to work effectively and efficiently with all Hollister team members and generate creative labeling solutions as labeling regulations evolve and change.
Serve as the Labeling Lead team member for Hollister Incorporated finished goods product labeling projects; SPRING (new product development), CPLR (country specific), CC (Change Control), CM (Contract Manufacturer), and Reimbursement labels.
Leads discussions, guides implementation and collaborates with functions (e.g., Research & Development, Regulatory, Corporate Communications, Packaging, Legal, etc.) to ensure all required US, EU and ROW essential labeling elements for finished goods product labels are documented and provided for labeling development per SKU.
Develops label content based on predicate product strategy and drives decisions to successfully deliver required, compliant finished good product labels (GLS labels, Label artwork, Package artwork).
Ensures product label content of an SKU is consistent and accurate across all labeling types (GLS labels, Label artwork, Package artwork, IFU)
Serves as an SME for Global Labeling processes, providing labeling support, training, and problem-solving assistance.
Responsible for the creation, revision and oversight of label content development procedures.
Works with and coordinates services with Contract Manufacturers, vendors and suppliers (for artwork, prints, proofs, label stock, etc.) to ensure execution of high-quality deliverables.
Effectively applies advanced knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of increased scope and complexity
Collaborates cross-functionally across time zones within Hollister
Work independently with minimal direction
Number of Overall Years Necessary: 5-8
Medical device or other health industry labeling development, preferred
Bachelor’s degree is required
Applied sciences preferred, business or arts considered.
Regulatory Affairs (RAC) or Project Management (PMP) Certification a plus
Specialized Skills/Technical Knowledge
Effective Technical Writing
Communicate clearly and provides direction to ensure completion of new and revised label content projects and initiatives.
Builds and strengthens relationships with other areas of the organization (i.e. IT, Packaging, and Development,) and other Business Sites and Vendors.
Strong knowledge and understanding of US, EU and ROW medical device labeling regulations; as well as overall FDA and MDD/MDR regulations; with commitment to learn and stay abreast of medical device labeling regulations desired.
Experience with label content development, labeling development, label formatting and configuration, and/or labeling system experience is preferred
Exceptional attention to detail skills; excellent follow-up, multi-tasking and organizational skills; clear and concise oral and written communication skills; and ability to work well with others.
Understanding of UDI labeling requirements, UDI processes and UDI GTIN Triggers.
Good understanding of how labeling processes and systems communicate with other systems.
Problem-solving skills including ability to analyze all aspects of a situation, identify potential solutions, make informed decisions and implement the solution in a timely manner.
Adaptability - Ability to take on new roles and responsibilities as they arise.
Proficient in Microsoft Office (Outlook, Excel, PowerPoint and Word)
Additional Salary Information: Commensurate with experience. Base pay plus 7.5% yearly target bonus.
Remote pending Covid. Individual should be local to come in to the office 3-4 days eventually.
Internal Number: 28607
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
We offer advanced medical products for Ostomy Care, which includes two strong global brands – Hollister Ostomy and Dansac Ostomy; Continence Care; and Critical Care. We also provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals.
Hollister has been serving healthcare professionals and patients for more than 95 years — making a difference in the journey of life for people throughout the global community.