Title: Sr Labeling Specialist

Location: Libertyville, IL, US, 60048-3781

Workplace: Full Time

Department: Quality

Job Description:

We Make Life More Rewarding and Dignified

Location: Libertyville Department: Quality

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. Hollister operates in a hybrid work environment.

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 (Labels, instructions for use and artwork, package and carton artwork, etc).
Ensures product label content of an SKU is consistent and accurate across all labeling types (Labels, instructions for use and artwork, package and carton artwork, etc).
Supports the development of Labeling design inputs/outputs for new products and review and alignment of labeling content with risk management file and other DHF documents.
Lead change control projects for simple to complex labeling changes.
Lead simple CAPAs for corrective actions in area of expertise.
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 &#39;essential functions&#39; necessary to perform this role. (for ADA purposes)

Requirements:

Number of Overall Years Necessary: 8-12
Medical device or other health industry labeling development, preferred
Bachelor&#39;s degree in applied sciences recommended, business experience considered.
Medical Device Labeling Standards and Regulations training, business experience considered.
Regulatory Affairs certification (RAC) preferred
Project Management and Change Control training

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 Subject Matter Expert 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.
Strong knowledge and understanding of UDI labeling requirements, UDI processes and UDI GTIN Triggers.
Strong 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.
Fluent in English

LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

The anticipated base pay range for this position is $109,000 - $156,000 yearly. The actual salary varies based on applicant&#39;s location, education, experience, skills, abilities, and other legitimate business factors.
If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan. The Company also provides a unique Benefit of Employee Share Ownership Program (BESOP) program based on earnings and length of service. 
The Company&#39;s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs. 
The Company&#39;s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions. 
The Company&#39;s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status. 
The Company&#39;s additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34353

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