Job Description

Labeling Content Specialist

Responsible for the effective cross-functional collaboration and indication of content for medical device labeling, packaging, and IFU (instructions for use) in compliance with international regulations, standards, and Hollister Incorporated labeling policies and procedures. This position will lead the development and revision of product labels for all Hollister and Dansac branded products to ensure continued compliance with regulations in the markets served to support user needs, according to the Hollister Incorporated Mission and Values.

This position is responsible for maintaining the Essential Labeling Elements database containing regulated medical device label requirements for each market served. This position requires an understanding of medical device labeling development processes and associated change management procedures and systems. This position must have the ability to work effectively and efficiently with all Hollister team members to generate creative labeling solutions as labeling regulations and standards evolve globally

Responsibilities:

• Serve as the primary representative of the Labeling department on projects including SPRING (new product development), CPLR (market expansion), CC (Change Control), CM (Contract Manufacturing), and CAPA (corrective and preventive action) projects.
• Lead discussions and collaborate with global functions (e.g., Research & Development, Regulatory, Clinical, Marketing, Packaging, Quality, Legal, Manufacturing, Master Data, etc.) to document essential labeling elements for global medical device label, IFU, and artwork development.
• Develops labeling content based on predicate product strategy and drives decisions to successfully deliver compliant finished good product labeling according to project schedules.
• Ensures product label content is consistent and accurate across all labeling types (e.g., device labels, package artwork, IFU, etc.)
• Collaborates with Labeling Developers, Graphic Designers, Contract Manufacturers, and other vendors for development of labels, artwork, prints, proofs, etc. to ensure execution of high-quality deliverables.
• Serves as an SME for Global Labeling processes and content, providing functional support, training, and problem-solving assistance.
• Responsible for the revision of label content development procedures.
• 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.

Note: This is not an exhaustive list of duties or functions and may not comprise of all \xe2\x80\x98essential functions\xe2\x80\x99 necessary to perform this role. (for ADA purposes)

Essential Functions of the Role**:

• Use of computer and accessories (monitor, keyboard, mouse)
• Familiarity with label printers desired

Work Experience Requirements

• Number of Overall Years Necessary: 5-8
• Medical device or other health industry labeling development, preferred

Education Requirements

• Bachelor\xe2\x80\x99s degree in applied sciences or language arts recommended, business experience considered.
• Regulatory Affairs (RAC) or Project Management (PMP) Certification a plus

Specialized Skills/Technical Knowledge:

• Strong technical writing skills and interpersonal communication (both written and oral).
• Communicates 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., Regulatory, Marketing, Clinical, Packaging, R&D, etc.) and other business sites and vendors.
• Knowledge and understanding of global medical device labeling regulations and standards including FDA and EU MDR regulations, with commitment to learn and stay abreast of evolving regulations and standards.
• Basic understanding of UDI labeling requirements, UDI databases, GS1 barcodes, and GTIN triggers preferred.
• Experience with label content development, labeling artwork development, label formatting and configuration, and/or labeling enterprise system experience is preferred.
• Exceptional attention to detail, 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 how labeling processes and systems interface with other processes and systems.
• Problem-solving skills including the ability to analyze all aspects of a situation, identify potential solutions, make informed decisions, and implement the solution in a timely manner.
• Adaptability \xe2\x80\x93 interest and ability to take on expanded responsibilities as opportunities arise.
• Proficient in Microsoft Office (Outlook, Excel, PowerPoint and Word).

Local Specifications (English and Local Language):

Fluent in English (written and oral)

Labeling Content Specialist

Hollister Incorporated