Product Labeling Specialist (Hybrid), Mid-Level

Jobright.ai; Eden Prairie (MN); Hybrid; USD 78,111 - 93,733; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading AI-powered career platform is seeking a Product Labeling Specialist to develop and manage product labeling strategies in a regulated environment. The ideal candidate has a minimum of 3 years experience in product labeling, strong communication skills, and project management capabilities. This hybrid position offers the opportunity to work with various stakeholders and ensure compliance with industry standards.

Qualifications

• Requires a minimum of 3 years of experience in product labeling.
• Must have working knowledge of domestic and international product labeling regulations.
• Excellent communication and teamwork skills required.

Responsibilities

• Manage labeling activities throughout the product lifecycle.
• Coordinate with internal stakeholders and external vendors for labeling production.
• Provide training and support to other departments regarding labeling requirements.

Skills

Product labeling experience

Communication skills

Problem-solving skills

Project management

Education

Minimum 3 years in product labeling

Tools

Labeling Management Systems

Microsoft Office Suite

Job description

Product Labeling Specialist (Hybrid), Mid-Level

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Product Labeling Specialist (Hybrid), Mid-Level

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Job Summary:

STERIS is dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. The Product Labeling Specialist is responsible for developing and maintaining product labeling and instructions for use, ensuring compliance with regulations, and collaborating with various departments to implement effective labeling strategies.

Responsibilities:

• Manages labeling activities throughout the product lifecycle: Oversees the creation, approval process, implementation (including reconciliation), and overall maintenance of labels and label data, including primary, secondary, and packaging components.

• Coordinates with internal stakeholders and external vendors to ensure timely and accurate labeling production, including translations, barcodes, lot, and expiration date requirements.

• Coordinates product labeling project tasks through the creation, development, completion, and release to production via the change process, determining the best resources to ensure projects are completed on time.

• Manages labeling activities throughout the product lifecycle: Oversees the creation, approval process, implementation (including reconciliation), and overall maintenance of labels and label data, including primary, secondary, and packaging components.

• Coordinates with internal stakeholders and external vendors to ensure timely and accurate labeling production, including translations, barcodes, lot, and expiration date requirements.

• Leads discussions, guides implementation, and collaborates with functions (e.g., Research & Development, Regulatory, Marketing, Packaging, Legal, etc.) to ensure that all required United States (US), European Union (EU), and Rest of World (ROW) essential labeling elements for finished goods product labels are documented and provided per item for labeling development, in compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards.

• Participate in refining current processes, troubleshooting problems, and documenting processes, procedures, and results.

• Ensures and verifies the accuracy and completeness of produced documentation, including proofreading, completing, and maintaining design control/project documentation, obtaining necessary approvals, and releasing it to operations for production.

• Demonstrates an excellent understanding of STERIS products and product labeling requirements, including branding, regulations, specifications, and language requirements.

• Demonstrates a thorough understanding of the STERIS engineering and design change process.

• Provides training and support to other departments regarding labeling requirements and procedures.

• Ability to collaborate effectively in a team environment and engage with various stakeholders, including Operations, Marketing, Regulatory Affairs, and Quality Assurance.

• Familiarity with labeling software and tools including Labeling Management Systems (LMS) and Microsoft Office Suite.

• Strong project management skills, effectively managing multiple projects and deadlines.

• Stay informed about industry trends: Continuously monitor industry trends, developments, and best practices related to labeling regulations, technology, and artwork creation.

• Proactively identify opportunities for process improvements, automation, and efficiency gains in labeling function.

Qualifications:

Required:

• Requires a minimum of 3 years of experience in product labeling encompassing areas such as color specifications, logo and branding compliance, trademark usage, Unique Device Identification (UDI), Globally Harmonized System (GHS) standards, regulatory labeling, Department of Transportation (DOT) requirements, market-specific labeling standards, and shipping regulations and instructional literature.

• Must have working knowledge of domestic and international product labeling and packaging regulations.

• Excellent communication and teamwork functional skills.

• Strong problem-solving skills.

• Experience working in a highly regulated environment under guidelines such as FDA, ISO, and BSI regulations.

• Ability to communicate technical concepts to various audiences in clear, concise language.

Preferred:

• 3+ years of experience with electronic desktop publishing equipment and layout programs.

• 3+ years of experience in product labeling within the medical device industry, with comprehensive end-to-end ownership.

• 3+ years of experience writing technical documents, emphasizing medical device operator manuals and instructional literature.

Company:

STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers. Founded in 1985, the company is headquartered in Mentor, Ohio, USA, with a team of 10001+ employees. The company is currently Public Company. STERIS has a track record of offering H1B sponsorships.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management

• Industries

  Software Development

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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