Product Labeling Specialist (Hybrid) (Eden Prairie, MN, US, 55344)

About the position

The Product Labelling Specialist is a multifaceted position that involves the development and maintenance of products and medical device labeling, instructions for use (IFUs), packaging, internal document control, change control, process control, and the implementation of required regulations and guidelines. This role is responsible for developing and implementing labeling strategies, processes, and procedures that align with the organization's strategic priorities. This Hybrid position requires working onsite 3 days per week in our STERIS Key Surgical Eden Prairie, MN location with the option of working 2 days from home during core business hours Monday to Friday. In this role you will partner with our location in Germany and must have availability for occasional early morning calls or meetings between the hours of 7am and 9am.

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.
• 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.

Requirements

• Bachelor's degree, 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.

Nice-to-haves

• 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.

Benefits

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add-on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career