Summary
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 regulations, standards, and associated change management. 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.
Responsibilities
- Serve as the Labeling team member for Hollister Incorporated finished goods product labeling projects for market expansion (CPLR) and changes to global regulations and labeling standards.
- Performs gap assessments for new labeling standards and revision to existing standards and leads and coordinates remediation plans for label compliance.
- Leads discussions, guides implementation and collaborates with functions (e.g., Research & Development, Regulatory, Marketing, 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)
- 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 essential functions necessary to perform this role. (for ADA purposes)
Essential Functions of the Role**:
- Use of computer and accessories (monitor, keyboard, mouse) and label printers
Work Experience Requirements
- Number of Overall Years Necessary: 5-8
- Medical device or other health industry labeling development, preferred
Education Requirements
- Bachelor's degree in applied sciences recommended, business experience considered.
- Regulatory Affairs certification (RAC) preferred
Specialized Skills/Technical Knowledge
- 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 and UDI regulations; as well as overall FDA and MDD/MDR regulations; with commitment to learn and stay abreast of medical device labeling regulations.
- Strong knowledge and understanding of medical device labeling standards, e.g., GS1 standards, ISO 15223-1, ISO 20417, EN 1041, IEC 60601-1, etc.
- Experience with label content development for medical devices or pharmaceuticals.
- 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.
- Knowledge of barcode symbology (GS1 barcodes, UPC-A, QR codes, etc.), ISO / ANSI print quality grading, and barcode verification preferred.
- 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).
- Effective technical writing.
Local Specifications (English And Local Language)
Fluent in English
Location - Gurgaon
Mode - Hybrid
